Industry Uneasy Over Interchangeability in Follow-On Biologics Bill

While viewing the follow-on biologics legislation recently passed by a Senate committee favorably, industry groups voiced concern over an interchangeability provision that could allow the FDA to supersede caregiver discretion in prescribing the products.

S. 1695, the Biologics Price Competition and Innovation Act, would allow the FDA to approve follow-on products to existing biologics. Once determined to be biosimilar to the reference product, a follow-on biologic could also be deemed interchangeable with the original product.

Under the bill, sponsored by Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Edward Kennedy (D-Mass.) and Sens. Mike Enzi (R-Wyo.), Hillary Rodham Clinton (D-N.Y.) and Orrin Hatch (R-Utah), the first interchangeable product approved would receive a year of marketing exclusivity.

Biotechnology Industry Organization (BIO) and PhRMA praised the senators for recognizing the importance of data exclusivity, but BIO maintains that the bill’s 12-year period of data exclusivity is not enough.

According to Bio President and CEO Jim Greenwood, “a strong case has been made that 14 years of data exclusivity is the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry, and to put biotechnology on a par with the up to 14 years of exclusivity provided through patent term protection for small-molecule pharmaceuticals under the Hatch-Waxman Act.”