Congressional Debate Continues on Data Exclusivity in Biosimilars Pathway

A recent article in the New York Times fairly captured the essence of the ongoing debate over the appropriate length of the period of data exclusivity to be included in a pathway for biosimilars:


"The trick is to allow competition without undermining the financial incentives the pharmaceutical industry needs to undertake the risky job of developing the next drugs for cancer and other diseases."


As you know, BIO believes competition will be good for the biotech industry. After all, we are innovators!  We just ask that the competition be fair and that the pathway for biosimilars achieve parity with the results of the Hatch-Waxman system for the approval of generic biologics.


As stated in BIO's full justification for the 14 years of data exclusivity we feel should be included in any pathway, generic drugs are on the market an average of 13.5 years without generic competition and biologics are on the market an average of 12.9 to 16.2 years before they break even. Without a sufficient period of data exclusivity, biotech companies, the vast majority of which do not have products on the market, will not be able to attract the investment necessary to get a potential therapy thru lengthy and expensive clinical trials and approval process at the Food and Drug Administration (FDA).


Expect to hear more on this topic as well as the critical issue of patient safety when the Energy and Commerce Committee continues its markup of the health care reform bill (H.R. 3200). Representatives Anna Eshoo (D, CA), Jay Inslee (D, WA) and Joe Barton (R, TX) are expected to introduce an amendment which encompasses the strengths of both the Pathway for Biosimilars Act , H.R. 1548, and the amendment overwhelmingly approved in the Senate Health, Education, Labor and Pensions Committee last week.