A bipartisan group of congressmen have introduced a bill that would create a simpler pathway for approving generic biotech drugs (or biogenerics). The bill, introduced by Henry Waxman and other Democrats and Republicans, is part of the Obama Administration's effort to lower the costs of the most expensive drugs.
Similar legislation has been proposed--and defeated--before. Branded and generic drugmakers have been at odds over how many competition-free years new drugs should have on the market. Biotech companies would like to see their products have 14 years on the market before competition kicks in. The Waxman proposal calls for five years of market exclusivity plus three more years for modified drugs--similar to the current guidelines for chemical drugs. The bill also gives the FDA the authority to decide which studies generic drugmakers will have to conduct in order to prove bioequivalence.
In a statement, BIO chairman Jim Greenwood had this to say: "The Biotechnology Industry Organization continues to support strongly the development of a pathway for the review and approval of biosimilars. Unfortunately, the legislation introduced today would take patients and our industry down the wrong path... This bill seeks to cut prices but instead cuts corners... The legislation introduced today does not strike the necessary balance for patients or the economy. Any biosimilars legislation must ensure safe and effective biosimilars, promote the continued development of new therapies and cures, and ensure the benefits of additional competition among biologics through the entry of biosimilars." If approved, some of the industry's bestselling biotech drugs--such as Enbrel, Remicade, Avastin, Herceptin, and many others--could be exposed to generic competition.
- check out the AP article
- see the WSJ report
- here's the BIO release