[Congressional Record Volume 153, Number 86 (Thursday, May 24, 2007)]
[Senate]
[Pages S6867-S6868]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GREGG (for himself, Mr. Burr, and Mr. Coburn):
  S. 1505. A bill to amend the Public Health Service Act to provide for 
the approval of biosimilars, and for other purposes; to the Committee 
on Health, Education, Labor, and Pensions.
  Mr. GREGG. Mr. President, next month the Senate Health, Education, 
Labor, and Pensions Committee is expected to markup legislation 
creating a regulatory pathway for the approval of follow-on biologics, 
or ``biosimilars''. I look forward to working with my colleagues on 
this important issue and would especially like to thank Senator Hatch 
for his leadership in this area.
  There are significant differences between small molecule drugs and 
larger protein derived therapeutic biologics. These differences are 
going to require a much more detailed and a much more complex approval 
pathway than the generic drug approval process. To protect patient 
safety, the FDA must be empowered to apply rigorous scientific 
standards to biosimilars seeking approval, while at the same time 
avoiding duplicative testing and unnecessary expense.
  Biological products are among the most promising and effective 
medicines for the treatment of serious and life-threatening diseases. 
Unfortunately these medicines are often very expensive, and current 
U.S. law does not provide an abbreviated approval pathway for ``follow-
on'' versions of these innovative products after key patents expire. 
Therefore, Congress should act so that patients can have access to less 
expensive versions of biologics, just as they do with generic small 
molecule drugs.
  In addition to the great benefits associated with biologic products, 
the American biotech industry has become the world leader in 
development of new therapies for serious or life-threatening illnesses. 
This will only continue as there are now at least 400 biologics 
currently in development. To preserve this incredibly innovative 
industry, biotechnology companies need to have a meaningful period of 
time to recoup the extraordinary expenses incurred in bringing these 
life-saving medicines to market. If not, U.S. based research and 
development of new biotech medicines will be threatened.
  Therefore, today I am introducing the Affordable Biologics for 
Consumers Act of 2007. It requires the FDA develop science-based rules 
for approval of biologics on a product-class basis. The legislation 
also provides 14 years of data exclusivity for innovator drug 
manufacturer products, with an additional 2 years available if the 
Secretary approves a new indication for the reference product. This 
legislation will ensure that patients have access to safe and 
affordable biologics, while protecting innovation and spurring the 
development of new life-saving therapies.
  I urge my colleagues to join me, and the many patient groups that 
have endorsed this legislation, in supporting this crucial piece of 
legislation.
  Mr. HATCH. Mr. President, I rise to commend our colleagues, Senators 
Gregg, Burr, and Coburn, for their introduction today of the Affordable 
Biologics for Consumers Act, S. 1505.
  As my colleagues are aware, I am the original author with 
Representative Henry Waxman of the Drug Price Competition and Patent 
Term Restoration Act, a law which gave rise to today's generic drug 
industry. And so, I have a long-standing interest in making certain 
that consumers have access to affordable medications and that we 
provide the appropriate incentives for development of the new products 
that are eventually to be copied.
  We must rectify the fact that there is no clear pathway for follow-on 
copies

[[Page S6868]]

of biological products, such as human growth hormone or insulin, to 
take two easy examples. And it must be rectified on a priority basis.
  That the Hatch-Waxman law did not cover these biologic products was 
not a simple omission. Indeed, the market for biologicals really did 
not develop until after enactment of Waxman-Hatch in 1984.
  For many years, I have worked toward development of a pathway for 
these ``follow-on'' products, but it was not until recently that I 
believe we have developed a public consensus that there is the 
scientific and regulatory underpinning necessary to write a good law.
  Comes now the Gregg-Burr-Coburn bill, which must be seen as an 
important contribution to the necessary dialog on follow-on biologics.
  The Gregg-Burr-Coburn proposal addresses elements which I believe are 
key to any law we enact. First, there must be sufficient incentive for 
the development of biologic products. That incentive is tied inherently 
to an appropriate protection of the innovator's intellectual property. 
And the protection must be for a sufficient length of time to allow 
inventors of the molecule and others who have a financial stake in its 
development to recoup the substantial time and investment necessary to 
invent a biologic. Such protections are key for biotechnology 
companies, large and small, but also for universities that conduct much 
of the research on new molecules and the other investors who support 
that promising research.
  Second, we should not create unnecessary barriers to marketing of 
lower-cost, successor biologic products. While the law must contemplate 
that the follow-on products be subjected to a rigorous scientific 
review to ensure they are safe, pure and potent, that review, however, 
should be flexible enough to make certain there are not unnecessary 
barriers to market entry for the lower-cost alternatives.
  Third, past history should inform our decision-making when it can, 
but any law we write must reflect the emerging realities of today's 
pharmaceutical market.
  And, finally, the law must reflect a careful balance. We all want 
consumers to have access to more affordable medications, and surely 
there is a need to allow patients to buy less expensive biological 
products. At the same time, we want to make certain that the 
abbreviated pathway for these follow-on biologics contemplates review 
of products which are truly follow-ons to the innovators' products, and 
not new biologics. This is tied inherently to the standard which is 
developed for ``similarity'' of the follow-on to the innovator.
  As many are aware, Senators Kennedy, Enzi, Clinton and I have been 
meeting for some time to discuss the elements that must be included in 
any follow-on biologics legislation. While I have been working on draft 
legislation for some time, I have not introduced a proposal pending a 
successful conclusion to those discussions. It has been our hope, and 
it remains our hope, that our meetings will lead to development of a 
consensus document that will provide the basis for the expected HELP 
Committee markup on June 13th.
  There is no doubt in my mind that the Gregg-Burr-Coburn proposal will 
help inform the discussions of we four Senators, and indeed the HELP 
Committee's deliberations on this issue. Senators Gregg, Burr and 
Coburn have a proven record in contributing greatly to the body of law 
we call the Food, Drug and Cosmetic Act. Their bill is a thoughtful and 
serious contribution and it is a significant work that this body should 
recognize.
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