[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1548 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1548

 To amend the Public Health Service Act to establish a pathway for the 
  licensure of biosimilar biological products, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 17, 2009

Ms. Eshoo (for herself, Mr. Inslee, Mr. Barton of Texas, Mr. Gene Green 
  of Texas, Ms. Baldwin, Mr. Rogers of Michigan, Mrs. Bono Mack, Mr. 
Hill, Mr. Upton, Mr. Barrow, Mr. Pitts, Mr. Thompson of California, Mr. 
    Capuano, Mrs. Davis of California, Mr. Bilbray, Mr. Dreier, Mr. 
Ellsworth, Mr. McGovern, Mr. Herger, Mr. Dent, Mr. Gerlach, Mr. Bishop 
of New York, Ms. Zoe Lofgren of California, Mr. Pence, Mr. Souder, Mr. 
 Honda, Mrs. Tauscher, Mr. Scalise, Mr. Towns, Mr. Crowley, Mr. Issa, 
  Mr. Patrick J. Murphy of Pennsylvania, Ms. Bean, Mr. Delahunt, Mr. 
     Smith of Washington, Mr. McCarthy of California, Mr. Neal of 
 Massachusetts, Mr. Lynch, Mr. Donnelly of Indiana, Mr. Hall of Texas, 
Mr. Lance, Mr. Holt, Mr. Nunes, and Mr. Kind) introduced the following 
 bill; which was referred to the Committee on Energy and Commerce, and 
   in addition to the Committee on the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to establish a pathway for the 
  licensure of biosimilar biological products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pathway for Biosimilars Act''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
            TITLE I--AMENDMENTS TO PUBLIC HEALTH SERVICE ACT

Sec. 101. Approval pathway for biosimilar biological products.
Sec. 102. Fees relating to biosimilar biological products.
                   TITLE II--AMENDMENTS TO PATENT ACT

Sec. 201. Amendments to certain patent provisions.

            TITLE I--AMENDMENTS TO PUBLIC HEALTH SERVICE ACT

SEC. 101. LICENSURE PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

    (a) Licensure of Biological Products as Biosimilar or 
Interchangeable.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended--
            (1) in subsection (a)(1)(A), by inserting ``under this 
        subsection or subsection (k)'' after ``biologics license''; and
            (2) by adding at the end the following:
    ``(k) Licensure of Biological Products as Biosimilar.--
            ``(1) In general.--Any person may submit an application for 
        licensure of a biological product under this subsection.
            ``(2) Content.--
                    ``(A) Required information.--An application 
                submitted under this subsection shall include 
                information demonstrating that--
                            ``(i) the biological product is biosimilar 
                        to a reference product based upon data derived 
                        from--
                                    ``(I) analytical studies that 
                                demonstrate that the biological product 
                                is highly similar to the reference 
                                product notwithstanding minor 
                                differences in clinically inactive 
                                components;
                                    ``(II) animal studies (including 
                                the assessment of toxicity); and
                                    ``(III) a clinical study or studies 
                                (including, but not limited to, the 
                                assessment of immunogenicity and 
                                pharmacokinetics or pharmacodynamics) 
                                that are sufficient to demonstrate 
                                safety, purity, and potency for each 
                                condition of use for which the 
                                reference product is approved;
                            ``(ii) the biological product and reference 
                        product utilize the same mechanism or 
                        mechanisms of action for the condition or 
                        conditions of use prescribed, recommended, or 
                        suggested in the proposed labeling, but only to 
                        the extent the mechanism or mechanisms of 
                        action are known for the reference product;
                            ``(iii) the condition or conditions of use 
                        prescribed, recommended, or suggested in the 
                        labeling proposed for the biological product 
                        have been previously approved for the reference 
                        product;
                            ``(iv) the route of administration, the 
                        dosage form, and the strength of the biological 
                        product are the same as those of the reference 
                        product; and
                            ``(v) the facility in which the biological 
                        product is manufactured, processed, packed, or 
                        held meets standards designed to assure that 
                        the biological product continues to be safe, 
                        pure, and potent.
                    ``(B) Waiver regarding analytical studies, animal 
                studies, and clinical studies.--
                            ``(i) In general.--The Secretary may, in 
                        the Secretary's discretion, determine that an 
                        element described in subclause (I), (II), or 
                        (III) of subparagraph (A)(i) is unnecessary and 
                        waive the requirement that such element be 
                        submitted in an application under this 
                        subsection.
                            ``(ii) Assessments of immunogenicity.--
                        Notwithstanding clause (i), the Secretary may 
                        determine that an assessment of immunogenicity 
                        described in subparagraph (A)(i)(III) is 
                        unnecessary and waive the requirement that such 
                        an assessment be submitted in an application 
                        under this subsection only if the Secretary has 
                        published a final guidance, following receipt 
                        and consideration of public comments on a draft 
                        guidance--
                                    ``(I) advising that it is feasible 
                                in the current state of scientific 
                                knowledge to make determinations on 
                                immunogenicity with respect to products 
                                in the product class to which the 
                                biological product belongs; and
                                    ``(II) explaining the data that 
                                will be required to support such a 
                                determination.
                    ``(C) Additional information.--An application 
                submitted under this subsection--
                            ``(i) shall include publicly available 
                        information regarding the Secretary's previous 
                        determination that the reference product is 
                        safe, pure, and potent; and
                            ``(ii) may include any additional 
                        information in support of the application, 
                        including publicly available information with 
                        respect to the reference product or another 
                        biological product.
            ``(3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) submitted under 
        this subsection, the Secretary shall approve the application 
        (or the supplement) if--
                    ``(A) the Secretary determines that the information 
                submitted in the application (or the supplement) is 
                sufficient to show that the biological product is 
                biosimilar to the reference product with respect to 
                each condition of use for which the reference product 
                is approved; and
                    ``(B) the applicant (or other appropriate person) 
                consents to the inspection of the facility that is the 
                subject of the application, in accordance with 
                subsection (c).
            ``(4) Safety standards for determining 
        interchangeability.--
                    ``(A) Determination.--Upon review of an application 
                submitted under this subsection or any supplement to 
                such application, the Secretary shall determine the 
                biological product to be interchangeable with the 
                reference product if the Secretary determines that the 
                information submitted in the application (or a 
                supplement to such application) is sufficient to show 
                that--
                            ``(i) the biological product--
                                    ``(I) is biosimilar to the 
                                reference product and any biological 
                                product licensed under this subsection 
                                that has been determined to be 
                                interchangeable with the reference 
                                product; and
                                    ``(II) can be expected to produce 
                                the same clinical result as the 
                                reference product in any given patient 
                                for each condition of use prescribed, 
                                recommended, or suggested in the 
                                labeling of the reference product; and
                            ``(ii) for a biological product that is 
                        administered more than once to an individual, 
                        the risk of alternating or switching between 
                        use of the biological product and the reference 
                        product (in terms of safety, diminished 
                        efficacy, and reduced or enhanced potency) is 
                        not greater than the risk of using the 
                        reference product without such alternation or 
                        switching.
                    ``(B) Guidelines.--Notwithstanding subparagraph 
                (A), the Secretary may not make a determination that a 
                biological product licensed under this subsection is 
                interchangeable with the reference product unless the 
                Secretary has published a final guidance, following 
                receipt and consideration of public comments on a draft 
                guidance--
                            ``(i) advising that it is feasible in the 
                        current state of scientific knowledge to make 
                        such determinations with respect to products in 
                        the product class to which that biological 
                        product belongs; and
                            ``(ii) explaining the data that will be 
                        required to support such a determination.
                    ``(C) Preservation of state authority.--Nothing in 
                this subsection shall be construed as preempting or 
                otherwise affecting the authority of a State to require 
                or regulate prescriptions.
            ``(5) General rules.--
                    ``(A) One reference product per application.--A 
                biological product, in an application submitted under 
                this subsection, may not be evaluated against more than 
                1 reference product.
                    ``(B) Review.--An application submitted under this 
                subsection shall be reviewed by the division within the 
                Food and Drug Administration that is responsible for 
                the review and approval of the application under which 
                the reference product is licensed.
                    ``(C) Risk evaluation and mitigation strategies.--
                The authority of the Secretary with respect to risk 
                evaluation and mitigation strategies under the Federal 
                Food, Drug, and Cosmetic Act shall apply to biological 
                products licensed under this subsection in the same 
                manner as such authority applies to biological products 
                licensed under subsection (a).
                    ``(D) Restrictions on biological products 
                containing dangerous ingredients.--If information in an 
                application submitted under this subsection, in a 
                supplement to such an application, or otherwise 
                available to the Secretary shows that a biological 
                product--
                            ``(i) is, bears, or contains a select agent 
                        or toxin listed in section 73.3 or 73.4 of 
                        title 42, section 121.3 or 121.4 of title 9, or 
                        section 331.3 of title 7, Code of Federal 
                        Regulations (or any successor regulations); or
                            ``(ii) is, bears, or contains a controlled 
                        substance in schedule I or II of section 202 of 
                        the Controlled Substances Act, as listed in 
                        part 1308 of title 21, Code of Federal 
                        Regulations (or any successor regulations);
                the Secretary shall not license the biological product 
                under this subsection unless the Secretary determines, 
                after consultation with appropriate national security 
                and drug enforcement agencies, that there would be no 
                increased risk to the security or health of the public 
                from licensing such biological product under this 
                subsection.
            ``(6) Exclusivity for first interchangeable biological 
        product.--The Secretary shall not make a determination under 
        paragraph (4) that a second or subsequent biological product is 
        interchangeable with the same reference product for which a 
        prior biological product has received a determination of 
        interchangeability until 24 months after the later of--
                    ``(A) the date of the first commercial marketing of 
                the first biosimilar biological product determined to 
                be interchangeable for that reference product; or
                    ``(B) with respect to a product marketed before the 
                date the product is determined to be interchangeable, 
                the date that the product is determined to be 
                interchangeable.
            ``(7) Exclusivity for reference product.--
                    ``(A) Effective date of biosimilar application 
                licensure.--Subject to subparagraph (D) and paragraph 
                (8), approval of an application under this subsection 
                may not be made effective by the Secretary until the 
                date that is 12 years after the date on which the 
                reference product was first licensed under subsection 
                (a).
                    ``(B) Filing period.--An application under this 
                subsection may not be submitted to the Secretary until 
                the later of--
                            ``(i) the date of commencement of a 
                        proceeding for issuance of guidance pursuant to 
                        paragraph (9) with respect to the product class 
                        within which the product that is the subject of 
                        such application falls; or
                            ``(ii) the date that is 4 years after the 
                        date on which the reference product was first 
                        licensed under subsection (a).
                    ``(C) First licensure.--For purposes of this 
                paragraph, the date on which the reference product was 
                first licensed under subsection (a) does not include 
                the date of approval of a supplement or of a subsequent 
                application for a new indication, route of 
                administration, dosage form, or strength for the 
                previously licensed reference product.
                    ``(D) Medically significant new indication.--If, 
                during the 8-year period following licensure of the 
                reference product, the Secretary approves a supplement 
                to the application for the reference product that seeks 
                approval to market the reference product for a new 
                indication that, if approved, would be a significant 
                improvement, compared to marketed products, in the 
                treatment, diagnosis, or prevention of disease, 
                approval of an application submitted under this 
                subsection may not be made effective by the Secretary 
                until the date that is 14 years after the date on which 
                the reference product was first licensed under 
                subsection (a).
            ``(8) Pediatric studies.--
                    ``(A) Exclusivity.--If, before or after licensure 
                of the reference product under subsection (a) of this 
                section, the Secretary determines that information 
                relating to the use of such product in the pediatric 
                population may produce health benefits in that 
                population, the Secretary makes a written request for 
                pediatric studies (which shall include a timeframe for 
                completing such studies), the applicant or holder of 
                the approved application agrees to the request, such 
                studies are completed using appropriate formulations 
                for each age group for which the study is requested 
                within any such timeframe, and the reports thereof are 
                submitted and accepted in accordance with section 
                505A(d)(3) of the Federal Food, Drug, and Cosmetic 
                Act--
                            ``(i) the period referred to in paragraph 
                        (7)(A) of this subsection is deemed to be 12 
                        years and 6 months rather than 12 years; and
                            ``(ii) if paragraph (7)(D) of this 
                        subsection applies, the period referred to in 
                        such paragraph is deemed to be 14 years and 6 
                        months rather than 14 years.
                    ``(B) Exception.--The Secretary shall not extend 
                the period referred to in subparagraph (A)(i) or 
                (A)(ii) of this paragraph if the determination under 
                section 505A(d)(3) of the Federal Food, Drug, and 
                Cosmetic Act is made later than 9 months prior to the 
                expiration of such period.
                    ``(C) Application of certain provisions.--The 
                provisions of subsections (a), (d), (e), (f), (h), (j), 
                (k), and (l) of section 505A of the Federal Food, Drug, 
                and Cosmetic Act shall apply with respect to the 
                extension of a period under subparagraph (A) of this 
                paragraph to the same extent and in the same manner as 
                such provisions apply with respect to the extension of 
                a period under subsection (b) or (c) of section 505A of 
                the Federal Food, Drug, and Cosmetic Act.
            ``(9) Guidance documents.--
                    ``(A) In general.--The Secretary shall, after 
                opportunity for public comment, issue final guidance 
                with respect to the licensure under this subsection of 
                a biological product or product class. Such guidance 
                shall be issued in accordance, except as provided in 
                subparagraph (B)(i), with section 701(h) of the Federal 
                Food, Drug, and Cosmetic Act.
                    ``(B) Public comment.--
                            ``(i) In general.--Before issuing final 
                        guidance under subparagraph (A), the Secretary 
                        shall publish a proposed guidance, provide an 
                        opportunity for the public to comment on the 
                        proposed guidance, and publish a response to 
                        comments received under this clause.
                            ``(ii) Input regarding most valuable 
                        guidance.--The Secretary shall establish a 
                        process through which the public may provide 
                        the Secretary with input regarding priorities 
                        for issuing guidance.
                    ``(C) Certain product classes.--
                            ``(i) Guidance.--The Secretary may indicate 
                        in a guidance document under subparagraph (A) 
                        that the Secretary will not license a product 
                        or product class (not including any recombinant 
                        protein) under this subsection because the 
                        science and experience, as of the date of such 
                        guidance, does not allow such licensure.
                            ``(ii) Modification or reversal.--The 
                        Secretary may issue a subsequent guidance 
                        document under subparagraph (A) to modify or 
                        reverse a guidance document under clause (i).
                    ``(D) Petition for initiation of guidance for 
                certain products.--In the case of a reference product 
                that was licensed by the Secretary more than 7 years 
                prior to the date of the enactment of the Pathway for 
                Biosimilars Act, a person may petition the Secretary at 
                any time to commence the process for issuing final 
                guidance under subparagraph (A) for the product class 
                to which the reference product belongs. Any such 
                petition shall include a description of the scientific 
                feasibility and rationale for the request. For guidance 
                petitioned under this subparagraph, the Secretary 
                shall, within 2 years of such petition, issue final 
                guidance with respect to that product class.
                    ``(E) Requirement for application consideration.--
                The Secretary may not accept an application under this 
                subsection until the Secretary has initiated a 
                proceeding for issuance of guidance with respect to the 
                product class within which the product that is the 
                subject of the application falls. The Secretary may not 
                approve an application under this subsection until the 
                Secretary has completed the proceeding for issuance of 
                guidance with respect to the product class within which 
                the product that is the subject of the application 
                falls.
                    ``(F) Requirement for product class-specific 
                guidance.--Product class-specific guidance issued under 
                subparagraph (A) shall include a description of--
                            ``(i) the criteria that the Secretary will 
                        use to determine whether a biological product 
                        is biosimilar to a reference product in such 
                        product class;
                            ``(ii) the criteria, if available, that the 
                        Secretary will use to determine whether a 
                        biological product meets the standards for 
                        interchangeability described in paragraph (4); 
                        and
                            ``(iii) the criteria, if available, that 
                        the Secretary will use to assess 
                        immunogenicity.
            ``(10) Naming.--The Secretary shall ensure that the 
        labeling and packaging of each biological product licensed 
        under this subsection bears a name that uniquely identifies the 
        biological product and distinguishes it from the reference 
        product and any other biological products licensed under this 
        subsection following evaluation against such reference product.
    ``(l) Patent Notices; Relationship to Final Approval.--
            ``(1) Definitions.--For the purposes of this subsection, 
        the term--
                    ``(A) `biosimilar product' means the biological 
                product that is the subject of the application under 
                subsection (k);
                    ``(B) `relevant patent' means a patent that--
                            ``(i) expires after the date specified in 
                        subsection (k)(7)(A) that applies to the 
                        reference product; and
                            ``(ii) could reasonably be asserted against 
                        the applicant due to the unauthorized making, 
                        use, sale, or offer for sale within the United 
                        States, or the importation into the United 
                        States of the biosimilar product, or materials 
                        used in the manufacture of the biosimilar 
                        product, or due to a use of the biosimilar 
                        product in a method of treatment that is 
                        indicated in the application;
                    ``(C) `reference product sponsor' means the holder 
                of an approved application or license for the reference 
                product; and
                    ``(D) `interested third party' means a person other 
                than the reference product sponsor that owns a relevant 
                patent, or has the right to commence or participate in 
                an action for infringement of a relevant patent.
            ``(2) Handling of confidential information.--Any entity 
        receiving confidential information pursuant to this subsection 
        shall designate one or more individuals to receive such 
        information. Each individual so designated shall execute an 
        agreement in accordance with regulations promulgated by the 
        Secretary. The regulations shall require each such individual 
        to take reasonable steps to maintain the confidentiality of 
        information received pursuant to this subsection and use the 
        information solely for purposes authorized by this subsection. 
        The obligations imposed on an individual who has received 
        confidential information pursuant to this subsection shall 
        continue until the individual returns or destroys the 
        confidential information, a court imposes a protective order 
        that governs the use or handling of the confidential 
        information, or the party providing the confidential 
        information agrees to other terms or conditions regarding the 
        handling or use of the confidential information.
            ``(3) Public notice by secretary.--Within 30 days of 
        acceptance by the Secretary of an application filed under 
        subsection (k), the Secretary shall publish a notice 
        identifying--
                    ``(A) the reference product identified in the 
                application; and
                    ``(B) the name and address of an agent designated 
                by the applicant to receive notices pursuant to 
                paragraph (4)(B).
            ``(4) Exchanges concerning patents.--
                    ``(A) Exchanges with reference product sponsor.--
                            ``(i) Within 30 days of the date of 
                        acceptance of the application by the Secretary, 
                        the applicant shall provide the reference 
                        product sponsor with a copy of the application 
                        and information concerning the biosimilar 
                        product and its production. This information 
                        shall include a detailed description of the 
                        biosimilar product, its method of manufacture, 
                        and the materials used in the manufacture of 
                        the product.
                            ``(ii) Within 60 days of the date of 
                        receipt of the information required to be 
                        provided under clause (i), the reference 
                        product sponsor shall provide to the applicant 
                        a list of relevant patents owned by the 
                        reference product sponsor, or in respect of 
                        which the reference product sponsor has the 
                        right to commence an action of infringement or 
                        otherwise has an interest in the patent as such 
                        patent concerns the biosimilar product.
                            ``(iii) If the reference product sponsor is 
                        issued or acquires an interest in a relevant 
                        patent after the date on which the reference 
                        product sponsor provides the list required by 
                        clause (ii) to the applicant, the reference 
                        product sponsor shall identify that patent to 
                        the applicant within 30 days of the date of 
                        issue of the patent, or the date of acquisition 
                        of the interest in the patent, as applicable.
                    ``(B) Exchanges with interested third parties.--
                            ``(i) At any time after the date on which 
                        the Secretary publishes a notice for an 
                        application under paragraph (3), any interested 
                        third party may provide notice to the 
                        designated agent of the applicant that the 
                        interested third party owns or has rights under 
                        1 or more patents that may be relevant patents. 
                        The notice shall identify at least 1 patent and 
                        shall designate an individual who has executed 
                        an agreement in accordance with paragraph (2) 
                        to receive confidential information from the 
                        applicant.
                            ``(ii) Within 30 days of the date of 
                        receiving notice pursuant to clause (i), the 
                        applicant shall send to the individual 
                        designated by the interested third party the 
                        information specified in subparagraph (A)(i), 
                        unless the applicant and interested third party 
                        otherwise agree.
                            ``(iii) Within 90 days of the date of 
                        receiving information pursuant to clause (ii), 
                        the interested third party shall provide to the 
                        applicant a list of relevant patents which the 
                        interested third party owns, or in respect of 
                        which the interested third party has the right 
                        to commence or participate in an action for 
                        infringement.
                            ``(iv) If the interested third party is 
                        issued or acquires an interest in a relevant 
                        patent after the date on which the interested 
                        third party provides the list required by 
                        clause (iii), the interested third party shall 
                        identify that patent within 30 days of the date 
                        of issue of the patent, or the date of 
                        acquisition of the interest in the patent, as 
                        applicable.
                    ``(C) Identification of basis for infringement.--
                For any patent identified under clause (ii) or (iii) of 
                subparagraph (A) or under clause (iii) or (iv) of 
                subparagraph (B), the reference product sponsor or the 
                interested third party, as applicable--
                            ``(i) shall explain in writing why the 
                        sponsor or the interested third party believes 
                        the relevant patent would be infringed by the 
                        making, use, sale, or offer for sale within the 
                        United States, or importation into the United 
                        States, of the biosimilar product or by a use 
                        of the biosimilar product in treatment that is 
                        indicated in the application;
                            ``(ii) may specify whether the relevant 
                        patent is available for licensing; and
                            ``(iii) shall specify the number and date 
                        of expiration of the relevant patent.
                    ``(D) Certification by applicant concerning 
                identified relevant patents.--Not later than 45 days 
                after the date on which a patent is identified under 
                clause (ii) or (iii) of subparagraph (A) or under 
                clause (iii) or (iv) of subparagraph (B), the applicant 
                shall send a written statement regarding each 
                identified patent to the party that identified the 
                patent. Such statement shall either--
                            ``(i) state that the applicant will not 
                        commence marketing of the biosimilar product 
                        and has requested the Secretary to not grant 
                        final approval of the application before the 
                        date of expiration of the noticed patent; or
                            ``(ii) provide a detailed written 
                        explanation setting forth the reasons why the 
                        applicant believes--
                                    ``(I) the making, use, sale, or 
                                offer for sale within the United 
                                States, or the importation into the 
                                United States, of the biosimilar 
                                product, or the use of the biosimilar 
                                product in a treatment indicated in the 
                                application, would not infringe the 
                                patent; or
                                    ``(II) the patent is invalid or 
                                unenforceable.
            ``(5) Action for infringement involving reference product 
        sponsor.--If an action for infringement concerning a relevant 
        patent identified by the reference product sponsor under clause 
        (ii) or (iii) of paragraph (4)(A), or by an interested third 
        party under clause (iii) or (iv) of paragraph (4)(B), is 
        brought within 60 days of the date of receipt of a statement 
        under paragraph (4)(D)(ii), and the court in which such action 
        has been commenced determines the patent is infringed prior to 
        the date applicable under subsection (k)(7)(A), (k)(7)(D), or 
        (k)(8) the Secretary shall make approval of the application 
        effective on the day after the date of expiration of the patent 
        that has been found to be infringed. If more than one such 
        patent is found to be infringed by the court, the approval of 
        the application shall be made effective on the day after the 
        date that the last such patent expires.
            ``(6) Limitations on actions for declaratory judgment.--
        With respect to a patent that is the subject of an explanation 
        under paragraph (4)(D)(ii), no action for a declaratory 
        judgment that the patent is invalid, unenforceable, or not 
        infringed may be brought under section 2201 of title 28, United 
        States Code, by an applicant prior to the date that is the 
        later of--
                    ``(A) 3 years prior to the date applicable under 
                subsection (k)(7)(A); or
                    ``(B) 120 days after such explanation has been 
                provided.''.
    (b) Products Previously Approved Under Section 505.--
            (1) Requirement to follow section 351.--Except as provided 
        in paragraph (2), an application for a biological product shall 
        be submitted under section 351 of the Public Health Service Act 
        (42 U.S.C. 262) (as amended by this Act).
            (2) Exception.--An application for a biological product may 
        be submitted under section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) if--
                    (A) such biological product is in a product class 
                for which a biological product in such product class is 
                the subject of an application approved under such 
                section 505 not later than the date of enactment of 
                this Act; and
                    (B) such application--
                            (i) has been submitted to the Secretary of 
                        Health and Human Services (referred to in this 
                        Act as the ``Secretary'') before the date of 
                        enactment of this Act; or
                            (ii) is submitted to the Secretary not 
                        later than the date that is 10 years after the 
                        date of enactment of this Act.
            (3) Limitation.--Notwithstanding paragraph (2), an 
        application for a biological product may not be submitted under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) if there is another biological product approved 
        under subsection (a) of section 351 of the Public Health 
        Service Act that could be a reference product with respect to 
        such application (within the meaning of such section 351) if 
        such application were submitted under subsection (k) of such 
        section 351.
            (4) Deemed approved under section 351.--An approved 
        application for a biological product under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be 
        deemed to be a license for the biological product under such 
        section 351 on the date that is 10 years after the date of 
        enactment of this Act.
            (5) Definitions.--For purposes of this subsection, the term 
        ``biological product'' has the meaning given such term under 
        section 351 of the Public Health Service Act (42 U.S.C. 262) 
        (as amended by this Act).

SEC. 102. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

    Subparagraph (B) of section 735(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g(1)) is amended by inserting ``, including 
licensure of a biological product under section 351(k) of such Act'' 
before the period at the end.

                   TITLE II--AMENDMENTS TO PATENT ACT

SEC. 201. AMENDMENTS TO CERTAIN PATENT PROVISIONS.

    Section 271(e)(2) of title 35, United States Code is amended--
            (1) in subparagraph (A), by striking ``or'' after 
        ``patent'';
            (2) in subparagraph (B), by adding ``or'' after the comma 
        at the end; and
            (3) by inserting the following after subparagraph (B):
                    ``(C) a statement under section 351(l)(4)(D)(ii) of 
                the Public Health Service Act,''.
                                 <all>