Agreement on biosimilars emerges

Washington, D.C.-There’s a lot of talk in Washington about the importance of enacting legislation to establish a pathway for FDA to approve “similar” or “follow-on” versions of biotech drugs. Biopharmaceutical companies have been pushing for compromise legislation this year, that is aligned with health insurers, pharmacy benefit managers, and public and private payers, who envision big savings.

Stakeholders see savings from access to generic versions of insulin, human growth hormone and erythropoietin, just to start.

Last year, leading senators developed a compromise follow-on biologics bill (S. 1695), but got stuck over language defining an exclusivity period for innovator therapies. Several biosimilar bills have been introduced in the House, but committee leaders have not taken any action on the issue.

Some agreement is emerging on key issues. Innovators and generics makers acknowledge that most biosimilars would warrant some clinical testing to assess immunogenicity and that the Food and Drug Administration should have flexibility to determine the viability of a proposed follow-on product. The main sticking point is over how long a data exclusivity period is needed to maintain incentives for innovation, as well as opportunities to develop follow-on products. If there’s a deal on these issues, the legislators could put together a compromise bill quickly and push it through with late-session must-pass budget legislation. But the details are complicated, and the betting is against any last-minute action this year.