[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1505 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1505

 To amend the Public Health Service Act to provide for the approval of 
                  biosimilars, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 24, 2007

   Mr. Gregg (for himself, Mr. Burr, and Mr. Coburn) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide for the approval of 
                  biosimilars, 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 ``Affordable Biologics for Consumers 
Act''.

SEC. 2. APPROVAL OF BIOSIMILARS.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended--
            (1) in subsection (j), by striking ``under subsection (a)'' 
        and inserting ``under subsection (a) or (k)''; and
            (2) by adding at the end the following:
    ``(k) Biosimilars.--
            ``(1) Application.--
                    ``(A) Submission.--Any person may submit an 
                application under this subsection for approval of a 
                biologics license for a biosimilar.
                    ``(B) Definitions.--In this subsection:
                            ``(i) Biosimilar.--The term `biosimilar' 
                        means a biological product that, in an 
                        application submitted under this subsection, is 
                        claimed to be similar to a qualified biological 
                        product (in this subsection referred to as the 
                        `reference product').
                            ``(ii) Qualified biological product.--The 
                        term `qualified biological product' means a 
                        biological product that is a biotechnology-
                        derived therapeutic biological product licensed 
                        under subsection (a) or a biotechnology-derived 
                        therapeutic protein product subject to an 
                        approved application that was submitted under 
                        section 505(b)(1) of the Federal Food, Drug, 
                        and Cosmetic Act.
            ``(2) Review and approval of biosimilar applications.--
                    ``(A) Review.--An application submitted under this 
                subsection for a biosimilar shall be reviewed--
                            ``(i) by the division that was responsible 
                        for review and approval of the reference 
                        product; and
                            ``(ii) in accordance with the procedures 
                        for review of biologics license applications 
                        established by the Secretary pursuant to 
                        subsection (a)(2)(A).
                    ``(B) Approval.--The Secretary shall approve the 
                application submitted under paragraph (1) only if--
                            ``(i) the applicant demonstrates that the 
                        biosimilar conforms to the applicable final 
                        product class-specific rule and, on the basis 
                        of the data submitted in conformance with such 
                        rule, the Secretary concludes the product is 
                        safe, pure, and potent;
                            ``(ii) the applicant demonstrates that the 
                        biosimilar is as similar to the reference 
                        product as may be achieved given the state of 
                        scientific knowledge and technology 
                        capabilities at the time of submission of the 
                        application;
                            ``(iii) the applicant demonstrates that the 
                        biosimilar has the same route of 
                        administration, dosage form, mechanism of 
                        action, and strength as the reference product;
                            ``(iv) the facility in which the biosimilar 
                        is manufactured, processed, packed, or held 
                        meets standards designed to assure that the 
                        biological product continues to be safe, pure, 
                        and potent; and
                            ``(v) 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).
                    ``(C) Conditions of approval.--The Secretary may 
                approve an application submitted under paragraph (1) 
                for a biosimilar--
                            ``(i) only for indications for which the 
                        reference product is approved;
                            ``(ii) only if, with respect to each such 
                        indication, the application conforms to the 
                        applicable final product class-specific rule, 
                        and on the basis of non-clinical and clinical 
                        data submitted regarding such indication, the 
                        Secretary concludes the product is safe, pure, 
                        and potent; and
                            ``(iii) only if the applicant agrees to 
                        provide to the Secretary, on an ongoing basis, 
                        all written documents it prepares for any 
                        purpose (including any patent litigation) that 
                        characterizes the difference between the 
                        biosimilar and the reference product.
            ``(3) Requests for issuance of product class-specific 
        rule.--
                    ``(A) In general.--Any person may submit a request 
                to the Secretary for the issuance of a product class-
                specific rule applicable to a qualified biological 
                product and its class.
                    ``(B) Priority.--The Secretary--
                            ``(i) in prioritizing among requests under 
                        this paragraph for a rule, shall consider 
                        likely market entry dates of biosimilars and 
                        the amount of time that will be needed to 
                        prepare the requested product class-specific 
                        rule; and
                            ``(ii) may summarily reject frivolous or 
                        unsupported requests.
                    ``(C) Issuance of rule.--
                            ``(i) In general.--In response to a request 
                        under this paragraph, the Secretary shall carry 
                        out notice and comment rulemaking procedures in 
                        accordance with clause (ii).
                            ``(ii) Procedures.--To publish product 
                        class-specific rules under this paragraph, the 
                        Secretary shall, in response to a request under 
                        this paragraph--
                                    ``(I) publish in the Federal 
                                Register a concept paper setting forth 
                                the specific questions to be addressed 
                                in the product class-specific rule and 
                                invite comments on the concept paper 
                                from any interested persons;
                                    ``(II) accept comments on the 
                                concept paper for not less than 4 
                                months;
                                    ``(III) consider the public 
                                comments on the concept paper;
                                    ``(IV) publish in the Federal 
                                Register the proposed product class-
                                specific rule and invite comments on 
                                the proposed rule from any interested 
                                persons;
                                    ``(V) accept comments on the 
                                proposed rule for not less than 6 
                                months;
                                    ``(VI) obtain the advice of the 
                                Biosimilars Advisory Committee with 
                                respect to the proposed rule; and
                                    ``(VII) except as provided in 
                                subparagraph (D), not later than 2 
                                years after receipt of the initial 
                                request, publish in the Federal 
                                Register the final product class-
                                specific rule or a determination that, 
                                given the current state of scientific 
                                and technical knowledge, it is not 
                                feasible to issue a product class-
                                specific rule setting forth data that 
                                will ensure the safety, purity, and 
                                potency of biosimilars to be covered by 
                                the rule.
                            ``(iii) Report to congress.--If the 
                        Secretary determines under clause (ii)(VII) 
                        that it is not feasible to issue the final 
                        class-specific rule in the 2-year period 
                        following the date of the applicable initial 
                        request, the Secretary shall submit to Congress 
                        a report that describes why Secretary was 
                        unable to issue such final rule and the plan 
                        and timeline of the Secretary for issuing such 
                        final rule.
                    ``(D) Consolidation of requests.--The Secretary may 
                consolidate requests submitted under this paragraph 
                that refer to closely related products or product 
                classes. If the Secretary chooses to consolidate such 
                requests, the Secretary shall publish the final product 
                class-specific rule or a determination described in 
                subparagraph (C)(ii)(VII) not later than 30 months 
                after receipt of the first request for a rule for any 
                product in the class.
            ``(4) Product class-specific rules.--
                    ``(A) In general.--A rule published under paragraph 
                (3) shall describe the data and information that will 
                be required in an application submitted under paragraph 
                (1).
                    ``(B) Required elements.--At a minimum, a rule 
                published under paragraph (3) shall require--
                            ``(i) data demonstrating the consistency 
                        and robustness of the manufacturing process for 
                        the active ingredient or active ingredients of 
                        the biosimilar and the finished formulation of 
                        the biosimilar;
                            ``(ii) data demonstrating the stability, 
                        compatibility (such as with excipients), and 
                        biological and physicochemical integrity of the 
                        active ingredient or active ingredients of the 
                        biosimilar;
                            ``(iii) data from physical, chemical, and 
                        biological assays fully characterizing the 
                        biosimilar, in comparison with the reference 
                        product, at both the active ingredient or 
                        active ingredients and finished product levels;
                            ``(iv) data from comparative nonclinical 
                        studies demonstrating that the biosimilar and 
                        the reference product have similar profiles in 
                        terms of pharmacokinetics, pharmacodynamics, 
                        toxicity, immunogenicity, and other relevant 
                        factors;
                            ``(v) data from comparative clinical trials 
                        demonstrating that the biosimilar and the 
                        reference product have similar profiles in 
                        terms of safety, purity, and potency, including 
                        pharmacokinetic studies, pharmacodynamic 
                        studies, immunogenicity studies, and trials of 
                        sufficient size and duration to demonstrate 
                        that the products are similar in their safety 
                        (in terms of nature, seriousness, and frequency 
                        of adverse reactions), purity, and potency 
                        profiles; and
                            ``(vi) data regarding postmarket assessment 
                        and monitoring of safety, purity, and potency, 
                        including, as appropriate, clinical trials, 
                        tests to investigate immunogenicity, patient 
                        registries, and other surveillance measures.
            ``(5) Revisions to rules.--If a new condition of use is 
        approved for a reference product after the latest publication 
        of the final product class-specific rule applicable to such 
        product, the Secretary shall promptly update and republish the 
        rule in accordance with paragraphs (3) and (4) (irrespective of 
        whether a request for such revision has been received under 
        paragraph (3)(A)) to address the data and information that will 
        be required in an application under this subsection for 
        approval of the new condition of use. The requirements of 
        paragraph (2)(C) shall apply if the new condition of use is a 
        new indication.
            ``(6) Biosimilars advisory committee.--
                    ``(A) Establishment.--The Secretary shall establish 
                a Biosimilars Advisory Committee (in this paragraph 
                referred to as the `Committee').
                    ``(B) Duties.--The Committee shall--
                            ``(i) provide expert scientific advice and 
                        recommendations to the Secretary regarding the 
                        development and approval of biosimilars; and
                            ``(ii) in formulating such advice and 
                        recommendations, provide interested persons 
                        with a reasonable opportunity to make written 
                        and oral presentations.
                    ``(C) Membership.--
                            ``(i) Qualifications.--The Secretary shall 
                        appoint to serve on the Committee individuals 
                        with expertise on therapeutic biological 
                        products, including manufacturing, safety, 
                        effectiveness, and other relevant matters. The 
                        Secretary shall ensure that the Committee 
                        consists of members with adequately diversified 
                        expertise and practical experience in such 
                        fields as clinical medicine, biological and 
                        physical sciences, pharmacoepidemiology and 
                        postmarket safety surveillance, and related 
                        professions.
                            ``(ii) Nominations.--In appointing members 
                        of the Committee, the Secretary shall provide 
                        an opportunity for scientific, industry, and 
                        consumer organizations and the public to 
                        nominate such members.
                            ``(iii) Nonvoting members.--The Committee 
                        shall include, as nonvoting members, 
                        representatives of patient organizations, 
                        manufacturers of innovative biological 
                        products, and manufacturers of biosimilars.
                            ``(iv) Supplemental membership.--For the 
                        purpose of developing a product class-specific 
                        rule under paragraphs (3) and (4), the 
                        Secretary may supplement the membership of the 
                        Committee, or arrange for advice from another 
                        advisory committee, in order to obtain the 
                        advice of individuals with special expertise 
                        relating to any product under review.
            ``(7) Time frames for application and authorization.--
                    ``(A) Submission of applications.--No application 
                for a biosimilar may be submitted under this subsection 
                unless--
                            ``(i) the Secretary has published under 
                        paragraph (3) a final product class-specific 
                        rule applicable to the reference product; and
                            ``(ii) not less than 12 years have elapsed 
                        from the date on which the reference product 
                        was approved or licensed.
                    ``(B) Effective date of approval.--Subject to 
                subparagraph (C), approval of an application submitted 
                under paragraph (1) shall not be made effective until 
                at least 14 years have elapsed from the date on which 
                the reference product was approved or licensed.
                    ``(C) Significant clinical benefit.--Approval of an 
                application submitted under paragraph (1) shall not be 
                made effective until at least 16 years have elapsed 
                from the date on which the reference product was 
                approved or licensed if--
                            ``(i) during the 12-year period following 
                        the approval or licensing of the reference 
                        product, the Secretary approves a supplement to 
                        the new drug or biologics license application 
                        for the reference product that seeks approval 
                        to market the reference product for a new 
                        indication; and
                            ``(ii) in the opinion of the Secretary, the 
                        new indication provides a significant clinical 
                        benefit.
                    ``(D) Supplement application of reference 
                product.--If, at any time following approval of the 
                reference product, the holder of the approved reference 
                product application submits a supplemental application 
                with new clinical data (other than bioavailability 
                data) to support a new condition of use (other than a 
                new indication with a significant clinical benefit 
                approved during the first 12 years after initial 
                product approval), and those data are essential to 
                approval of the supplemental application, the Secretary 
                may not approve an application for a biosimilar for the 
                new condition of use for 3 years following approval of 
                the supplement.
                    ``(E) Exclusive approval pathway.--The Secretary 
                may not approve, under any other provision of law, a 
                product that is claimed to be similar to or the same as 
                a reference product.
                    ``(F) Approval of biosimilar application with 
                respect to older reference products.--Notwithstanding 
                any other provision of this subsection, an application 
                submitted under paragraph (1) that relies on a 
                reference product approved more than 14 years before 
                the date of enactment of this subsection may be made 
                effective on the date that is the later of--
                            ``(i) the publication of a product class-
                        specific rule under paragraph (3) in which the 
                        reference product is included; or
                            ``(ii) 1 year after the date of enactment 
                        of this subsection.
                    ``(G) Transition.--If, during the period following 
                the approval of a reference product that was approved 
                more than 14 years before the date of enactment of this 
                subsection but before the publication of a product 
                class-specific rule under paragraph (3) in which the 
                reference product is included, the holder of the 
                approved reference product application obtains approval 
                of a new indication with a significant clinical benefit 
                as determined by the Secretary, approval of an 
                application submitted under paragraph (1) that relies 
                on such reference product may not be made effective 
                under 16 years after the date of approval of the 
                reference product.
            ``(8) Patent notifications and linkages.--
                    ``(A) Notification.--When an application for a 
                biosimilar is submitted, the Secretary shall publish a 
                notice in the Federal Register identifying--
                            ``(i) the sponsor of the application of the 
                        reference product upon which the application 
                        for the biosimilar relies; and
                            ``(ii) the name of the sponsor of the 
                        application for the biosimilar, or an agent 
                        designated by such sponsor to receive 
                        communications regarding patents.
                    ``(B) Information from patent holder.--
                            ``(i) In general.--A patent owner may--
                                    ``(I) request information from the 
                                person that submits an application for 
                                a biosimilar under paragraph (1) to 
                                ascertain whether such person's product 
                                or processes would infringe on a patent 
                                of the patent owner;
                                    ``(II) provide such person or its 
                                designee a notice of patents that may 
                                be infringed by the production or sale 
                                of the biosimilar, such as patents on 
                                compound (protein sequence), 
                                composition, host cell, nucleic acid, 
                                process of production, and method of 
                                treatment patents; or
                                    ``(III) indicate with such 
                                notification whether the patent holder 
                                is open to licensing the patent rights 
                                on a non-exclusive basis.
                            ``(ii) No declaratory judgment.--A patent 
                        designated as available for licensure pursuant 
                        to clause (i)(III) may not be the subject of a 
                        declaratory judgment action brought by the 
                        biosimilar applicant prior to approval of the 
                        application for a biosimilar under this 
                        subsection.
                    ``(C) Written explanation.--
                            ``(i) In general.--A person that submits an 
                        application for approval of a biosimilar under 
                        this subsection that requests approval prior to 
                        the expiration of a patent identified by a 
                        patent owner shall provide to such patent 
                        owner, a written explanation of--
                                    ``(I) why the patent identified in 
                                subparagraph (B)(i) would not be 
                                infringed by the approval of the 
                                application for the biosimilar; or
                                    ``(II) why the identified patent is 
                                invalid.
                            ``(ii) Compliance.--With respect to process 
                        of manufacture patents, the biosimilar 
                        applicant must comply with the requirements of 
                        section 295 of title 35, United States Code.
                    ``(D) Approval date.--Approval of an application 
                for a biosimilar submitted under this subsection may be 
                effective on the applicable date described in paragraph 
                (7) even if patent litigation has not concluded. If a 
                patent is found valid and infringed before approval of 
                the application for a biosimilar, and the patent 
                expires after the applicable effective date of the 
                biosimilar application described in paragraph (7), 
                approval of the biosimilar application may not be 
                effective until the expiration of the infringed patent.
                    ``(E) Declaratory judgment action.--A person that 
                submits an application for a biosimilar under this 
                subsection may not commence a declaratory judgment 
                action concerning a patent identified in subparagraph 
                (B)(i) later than 18 months before the applicable 
                effective date of the biosimilar application described 
                in paragraph (7), or the date that is 60 days after 
                providing the written explanation in subparagraph (C) 
                of this paragraph, if such provision occurs during the 
                18-month period before the applicable effective date of 
                the biosimilar application described in paragraph (7).
            ``(9) Exclusivity of biosimilars.--The Secretary may not 
        approve an application for a biosimilar that relies on a 
        reference product for 1 year after the date of approval of the 
        first biosimilar application that relies on such reference 
        product.
    ``(l) Proper Name.--For purposes of this section:
            ``(1) Biotechnology-derived therapeutic proteins.--
                    ``(A) In general.--Subject to subparagraph (D), the 
                term `proper name', with respect to a biotechnology-
                derived therapeutic protein, means--
                            ``(i) the name adopted for such protein by 
                        the United States Adopted Names Council if such 
                        name is a unique USAN; or
                            ``(ii) if the biotechnology-derived 
                        therapeutic protein lacks a unique USAN, an 
                        official name designated pursuant to 
                        subparagraph (C).
                    ``(B) Unique usan.--The term `unique USAN', with 
                respect to a biotechnology-derived therapeutic protein, 
                means a name adopted for such protein by the United 
                States Adopted Names Council that has not been adopted 
                for any protein manufactured by a different person.
                    ``(C) Designation.--The Secretary shall designate 
                an official name for any biotechnology-derived 
                therapeutic protein that lacks a unique USAN. Any 
                official name designated under this subparagraph shall 
                be the only official name of that protein used in any 
                official compendium published after such name has been 
                designated. In no event, however, shall the Secretary 
                designate an official name so as to infringe a valid 
                trademark. Any designation under this subparagraph 
                shall be made by rule in accordance with section 553 of 
                title 5, United States Code.
                    ``(D) Exception.--The term `proper name', with 
                respect to a biotechnology-derived therapeutic protein 
                that was licensed by the Secretary prior to the 
                effective date of the Affordable Biologics for 
                Consumers Act, means the name adopted for such protein 
                by the United States Adopted Names Council, 
                irrespective of whether such name is a unique USAN.
            ``(2) Other biological products.--The term `proper name', 
        with respect to a biological product that is not a 
        biotechnology-derived therapeutic protein, means--
                    ``(A) the official name designated by the Secretary 
                for such biological product pursuant to section 508 of 
                the Federal Food, Drug, and Cosmetic Act;
                    ``(B) if there is no such official name and such 
                biological product is an article recognized in an 
                official compendium, the official title thereof in such 
                compendium; or
                    ``(C) if neither subparagraph (A) nor subparagraph 
                (B) applies, the common or usual name, if any, of such 
                biological product.
    ``(m) Interchangeability.--
            ``(1) In general.--
                    ``(A) No designation of interchangeability or 
                therapeutic equivalence.--The Secretary may not 
                designate a biosimilar as interchangeable with (or 
                therapeutically equivalent to) the applicable reference 
                product.
                    ``(B) Assessment.--Not later than 2 years after the 
                date of enactment of this subsection, and every 2 years 
                thereafter, the Secretary shall assess the state of 
                scientific and technical knowledge regarding the 
                ability of the Food and Drug Administration to make a 
                determination that a biosimilar is interchangeable with 
                (or therapeutically equivalent to) a reference product 
                on a product class basis.
            ``(2) Determination.--If the Secretary finds that the state 
        of scientific and technical knowledge enables the Food and Drug 
        Administration to make a determination of interchangeability 
        (or therapeutic equivalence) with respect to 1 or more product 
        classes, then the Secretary shall submit a report to Congress 
        that describes such findings and recommendations for statutory 
        criteria that should govern such a determination.''.
    (b) Confidentiality.--Subsection (j) of section 351 of the Public 
Health Service Act (42 U.S.C. 262), as amended by subsection (a)(1), is 
further amended by adding at the end the following: ``The Secretary 
shall maintain the confidentiality of information submitted under this 
section for a biological product to the same extent and in the same 
manner as the Secretary maintains the confidentiality of information 
submitted under section 505 of the Federal Food, Drug, and Cosmetic Act 
for a drug.''.
    (c) Patent Actions.--
            (1) Infringement action.--Section 271(e)(2) of title 35, 
        United States Code, is amended--
                    (A) in subparagraph (A), by striking ``, or'' and 
                inserting a comma;
                    (B) in subparagraph (B), by striking ``patent,'' 
                and inserting ``patent, or''; and
                    (C) by adding after subparagraph (B) the following:
                    ``(C) a written explanation described in section 
                351(k)(8)(C)(i) of the Public Health Service Act,''.
            (2) Patent term authority.--Section 156(b) of title 35, 
        United States Code, is amended by adding at the end before the 
        period, the following: ``, and shall extend to any product that 
        is the subject of an application approved under section 351(k) 
        of the Public Health Service Act''.

SEC. 3. AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Labeling.--
            (1) Unique name.--Section 502 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
        end the following:
    ``(y) If it is a biotechnology-derived therapeutic protein, it was 
licensed under section 351 of the Public Health Service Act prior to 
the effective date of the Affordable Biologics for Consumers Act, it 
lacks a unique USAN, and its labeling fails to bear (i) its proper name 
(as defined in section 351(l) of the Public Health Service Act); (ii) 
its brand name or phrasing, approved by the Secretary, that adequately 
distinguishes it from other approved biotechnology-derived therapeutic 
proteins with the same proper name; and (iii) the following warning: 
`Any change in ___________, including a change in manufacturer, should 
be made cautiously and only if authorized by and supervised by the 
prescribing health care professional.', with the proper name of the 
product being inserted in the blank space. The requirement in the 
preceding sentence regarding the inclusion of a warning applies 
beginning on the date that is 180 days after the date of the enactment 
of the Affordable Biologics for Consumers Act.
    ``(z) If it is a biotechnology-derived therapeutic protein not 
subject to paragraph (y), and its labeling fails to include (i) its 
proper name (as defined in section 351(l) of the Public Health Service 
Act); and (ii) the following warning: `This product shall not be 
dispensed in substitution for another biological product that was 
prescribed to be dispensed, unless such substitution was expressly 
authorized by and is supervised by the prescribing health care 
professional.'. In the case of such a protein that is a biosimilar 
licensed under section 351(k) of the Public Health Service Act, the 
warning required by the preceding sentence shall read as follows: `This 
product shall not be dispensed in substitution for another biological 
product that was prescribed to be dispensed including _________.', with 
the proprietary name and proper name of the reference product being 
inserted in the blank space.
    ``(aa) If it is a biosimilar approved under section 351(k) of the 
Public Health Service Act and the labeling--
            ``(1) is inconsistent with the labeling of the reference 
        product (as referred to in such section 351(k));
            ``(2) does not accurately characterize the biosimilar or 
        account for any differences between the biosimilar and the 
        reference product;
            ``(3) does not describe any new data submitted in support 
        of approval of the biosimilar since the date of approval of the 
        reference product;
            ``(4) does not disclose any special safety concerns 
        identified with respect to the biosimilar; or
            ``(5) omits any safety information, such as adverse events, 
        that are identified with respect to, and included in the 
        labeling of, the reference product, unless sponsor of such 
        biosimilar justifies such omission to the Secretary.''.
    (b) Dispensing.--Section 503(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353(b)) is amended by adding at the end the 
following:
    ``(6) A drug that is subject to paragraph (1) and is a 
biotechnology-derived therapeutic protein licensed under section 351 of 
the Public Health Service Act shall not be dispensed unless the 
prescription specifies the drug's proprietary name or, if the drug 
lacks a proprietary name, the drug's proper name (as defined in section 
351(l) of such Act). The act of dispensing a drug contrary to the 
preceding sentence shall be deemed to be an act which results in the 
drug being misbranded while held for sale.''.

SEC. 4. REPORT TO CONGRESS.

    Not later than 2 years after the date of the enactment of this Act, 
and every 2 years thereafter, the Secretary of Health and Human 
Services shall submit a report to the Congress making recommendations 
on whether it is feasible, in the state of scientific and technical 
knowledge (as of the date of such report), to approve applications 
under section 351(k) of the Public Health Service Act, as added by 
section 2 of this Act, for biological products that are claimed to be 
similar to vaccines, blood or plasma products or their derivatives, 
gene therapy, cell processing, naturally derived therapeutic proteins, 
or other biological products that do not contain biotechnology-derived 
therapeutic proteins as any active ingredient.
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