[Congressional Record (Bound Edition), Volume 155 (2009), Part 6]
[Extensions of Remarks]
[Pages 7683-7684]
[From the U.S. Government Publishing Office, www.gpo.gov]




            INTRODUCTION OF THE PATHWAY FOR BIOSIMILARS ACT

                                 ______
                                 

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                        Tuesday, March 17, 2009

  Ms. ESHOO. Madam Speaker, the field of biotechnology is the future of 
medicine. Scientists and doctors are just beginning to scratch the 
surface of the potential to harness the extraordinary power of biology 
and the astounding natural processes which occur in the human body, in 
animals, and in other living organisms to advance breakthrough medical 
discoveries and treatments. While ordinary pharmaceuticals primarily 
treat the symptoms of a disease or illness, biotechnology products--
``biologics''--can be manipulated to target the underlying mechanisms 
and pathways of a disease.
  Through the study of biotechnology, the potential exists to develop 
effective treatments for cancer and AIDS, many of which are already 
saving lives. We will cure diabetes. We will prevent the onset of 
deadly and debilitating diseases such as Alzheimer's, heart disease, 
Parkinson's, multiple sclerosis and arthritis. We will save millions of 
lives and improve countless more.
  The development of biologics is expensive and extremely risky. 
Bringing a biologic to market can require hundreds of millions of 
dollars in research and development costs and can take several years. 
For every successful biologic, there are another 10 or 20 that do not 
pan out, making the incentives for investment in this field extremely 
sensitive for any changes in the regulatory structure for biologics.
  In 1984 the highly successful Hatch-Waxman Act was enacted, 
establishing a new market for generic versions of pharmaceuticals. 
Today, patients can buy generic drugs that are safe and save them money 
compared with brand name drugs. The Pathway for Biosimilars Act will 
accomplish the same thing for biologics.
  In the relatively young industry of biotechnology, many of the 
original patents on biologics are beginning to expire and it's 
appropriate for Congress to consider how ``follow-on'' biologics or 
``biosimilars'' are considered and approved by the FDA, and the impact 
these products will have on patient health and safety, health care 
costs, and incentives for innovation.
  As a primary matter, it's important to recognize that traditional 
``small-molecule'' pharmaceuticals and biologics are fundamentally 
different in their development, their manufacture and their chemical 
makeup. A traditional small-molecule drug is manufactured through 
synthesis of chemical ingredients in an ordered process, and the 
resulting product can be easily identified through laboratory analysis. 
A biologic is a large, complex molecule, which is ``grown'' in living 
systems such as a microorganism, a plant or animal cell. The resulting 
protein is unique to the cell lines and specific process used to 
produce it, and even slight differences in the manufacturing of a 
biologic can alter its nature. As a result, biologics are difficult, 
sometimes impossible to characterize, and laboratory analysis of the 
finished product is insufficient to ensure its safety and efficacy.
  The pharmaceutical drug production process is easily replicated and a 
``generic'' drug product is virtually identical to the original 
innovative product, so generic drug manufacturers are permitted to 
reference the original testing data submitted by the innovator 
companies when the original drug is submitted to the FDA for approval. 
With biologics, the manufacturing process is unique to each biologic 
and is not generally disclosed as part of the published patent. A 
biosimilar manufacturer would have to have intimate knowledge of these 
proprietary processes in order to ``duplicate'' the biologic product, 
and even then it is extremely difficult--no two living cell lines are 
identical, so no two biologics manufacturing processes have identical 
starting materials or proceed in the same way.
  It's also important to note that because biologics are produced with 
cells from living organisms, many of them can cause an immune reaction 
which is normally benign and does not affect safety. However, some of 
these reactions can negate the effectiveness of the biologic or even 
cause side effects that are more dangerous. Most of these reactions can 
only be observed through clinical trials with real patients.
  Any expedited regulatory pathway for biosimilars must account for all 
these factors and I'm proud to join with Congressman Jay Inslee and the 
Ranking Member of the Energy and Commerce Committee, Rep. Joe Barton, 
to introduce the Pathway for Biologics Act. Our bill builds on the 
significant progress the Senate, led by Senators Kennedy and Enzi, 
already made during the last Congress, as well as the significant level 
of consensus we have heard on our Committee about this issue. The 
Pathway for Biologics Act will establish a new statutory pathway for 
biosimilars guided by three principles:
  1. Legislation to facilitate the development of biosimilars should 
promote competition and lower prices, but patient safety, efficacy and 
sound science must be paramount.
  2. We must preserve incentives for innovation and ensure that 
patients will continue to benefit from the ground-breaking treatments 
biotechnology alone can bring.
  3. We must strive to protect the rights of all parties and resolve 
disputes over patents in a timely and efficient manner that does not 
delay market entry and provides certainty to all parties.
  The regulatory pathway set forth in the Pathway for Biologics Act 
embodies each of these principles and sets forth a sensible, 
scientifically sound process for approval of biosimilars. The 
legislation allows for input from all interested parties and provides 
FDA appropriate flexibility to protect patient health by requesting 
analytical, animal and clinical studies to demonstrate the safety, 
purity and potency of a biosimilar. The FDA will be empowered to 
require the tests and data it deems necessary, but the results of 
clinical testing for immunogenicity will always be required as part of 
this data unless the FDA has published final guidance documents 
advising that such a determination is feasible in the current state of 
science absent clinical data and explaining the data that will be 
required to support such a determination. Since biologics are derived 
from human and animal products, immune reactions are a major concern 
for any new biologic product and are now impossible to detect without 
actual human testing.
  Our legislation also addresses the important issue of 
interchangeability of biosimilars for the reference product. Some 
legislative proposals would allow the FDA to permit pharmacists and 
insurers to substitute a biosimilar for a physician's prescription for 
an innovator biologic product even when they cannot be demonstrated to 
be identical in their composition or effectiveness. Interchangeability 
of generic pharmaceuticals for brand name drugs is entirely appropriate 
since traditional generic drugs are chemically identical to the 
reference product. However, if the state of science is such that a 
complex molecule cannot be fully characterized and a precursor biologic 
cannot be adequately compared to a proposed biosimilar, then the 
biosimilar should not be fully substitutable for the precursor product 
without a physician's direction. The Pathway for Biologics Act makes it 
clear that the FDA cannot make a determination that a biosimilar is 
interchangeable with a reference product until it has published final 
guidance documents advising that it is feasible in the current state of 
scientific knowledge to make such determinations with respect to the 
relevant product class and explaining the data that will be required to 
support such a determination. This requirement is consistent with the 
recommendations of the Chief Scientist of the FDA.
  An essential element of any new regulatory scheme for the biotech 
industry is a careful balancing of incentives for innovation and 
opportunities for new entry by competitors. To preserve incentives for 
innovation, the Pathway for Biologics Act provides 12 years of data 
exclusivity for new biologic products, which ensures that biosimilar 
applications that rely on the safety and efficacy record of existing 
biologic products will not be permitted to enter the market for 12 
years following the approval of the innovator product. The 12-year 
exclusivity period is meant to preserve existing protections biotech 
companies receive from patents. The Congressional Budget Office has 
found that the effective patent life for pharmaceuticals is about 11.5 
years, so a data exclusivity period of 12 years is consistent with that 
finding. Data exclusivity is necessary to provide additional 
protections and incentives for biologics because biosimilars--unlike 
generic drugs--will not be chemically identical to the reference 
product and will be less likely to infringe the patents of the 
innovator.
  The legislation also includes incentives for additional indications 
and pediatric testing. New indications are critical for biologics and 
are often more significant than the indications for which approval was 
granted. Incentives for continued testing on new indications must be 
included to promote access to new treatments and cures, and this bill 
provides an additional two years exclusivity for new indications. I 
also believe it's important to provide incentives

[[Page 7684]]

similar to those given traditional pharmaceuticals under the Best 
Pharmaceuticals for Children Act to biologics, so the legislation 
provides an additional six months of data exclusivity for testing for 
use in pediatric groups.
  In order to protect the rights of all parties and ensure that all 
patent disputes involving a biosimilar are resolved before the 
expiration of the data exclusivity period, the Pathway for Biosimilars 
Act establishes a simple, streamlined patent resolution process. This 
process would take place within a short window of time--roughly 6-8 
months after the biosimilar application has been filed with the FDA. It 
will help ensure that litigation surrounding relevant patents will be 
resolved expeditiously and prior to the launch of the biosimilar 
product, providing certainty to the applicant, the reference product 
manufacturer, and the public at large. The legislation also preserves 
the ability of third-party patent holders such as universities and 
medical centers to defend their patents.
  Once a biosimilar application is accepted by the FDA, the agency will 
publish a notice identifying the reference product and a designated 
agent for the biosimilar applicant. After an exchange of information to 
identify the relevant patents at issue, the applicant can decide to 
challenge any patent's validity or applicability. All information 
exchanged as part of this procedure must be maintained in strict 
confidence and used solely for the purpose of identifying patents 
relevant to the biosimilar product. The patent owner will then have two 
months to decide whether to enforce the patent. If the patent owner's 
case is successful in court, the final approval of the application will 
be deferred until the patent expires.
  Madam Speaker, I believe the Pathway for Biosimilars Act sets forth a 
straightforward, scientifically based process for expedited approval of 
new biologics based on innovative products already on the market. This 
new biosimilars approval pathway will promote competition and lower 
prices, but also ensure that patients are given safe and effective 
treatments that have been subjected to thorough scrutiny and testing by 
the FDA. The Pathway for Biosimilars Act will also protect the rights 
of patent holders and preserve incentives for innovation in the 
biotechnology sector to develop the next generation of life-saving, 
life-changing therapies.
  I strongly urge my colleagues to support the Pathway for Biosimilars 
Act.

                          ____________________