Congresswoman To Submit Biogenerics Legislation

Some wags say the debate over biologics may not go anywhere this year, but one congresswoman is supposedly on the verge of introducing a bill to resolve the controversy. Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has drafted legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, according to the FDA Law blog.

The draft would amend the Public Health Service Act by adding a section that would allow biologic licenses to be submitted and include info demonstrating the med is biosimilar based on analytical studies, animal studies, and a clinical study or studies (such as an immunogenicity assessment and pharmacokinetics or pharmacodynamics). Under certain circumstances, the studies may be waived by the Department of Health and Human Services. (Here’s the bill).

The legislation goes on to propose that HHS “may not accept a biogeneric application until a proceeding has been initiated for the issuance of a guidance document for the product class in which the biogeneric falls, and (HHS) may not approve a biogeneric application until that proceeding is completed,” the blog notes.

The sponsor of the first biogeneric determined to be interchangeable may receive a 24-month period of market exclusivity. In exchange, innovator companies would receive 12-year exclusivity, which may be increased to 14-1/2 years if, during the 8-year period following licensure, the HHS approves a supplement for a new indication that would be a “significant improvement” compared to marketed products. Another 6 months could be tacked on if a supplemental application to support use in pediatric age groups is submitted. The trade group for generic drugmakers, however, is on record as opposing such lengthy exclusivity for ‘innovators.’

Many biotechs are frustrated with the lack of progress in Washington at creating an FDA pathway for approving biologics, and have stepped up their lobbying. As an aside, pharma is listed as the third-largest contributor, among industries, to Eshoo, according to the Center for Responsive Politics.

Hat tip to the FDA Law blog