Report: FDA readies release of long-awaited rules on biosimilars

Despite increasingly loud groans from the payer community in healthcare, the FDA has demonstrated repeatedly that it plans to take its time to craft a regulatory pathway for biosimilars. Its current schedule calls for a set of rules by the end of the year. But the long wait may be drawing to an end, with a top regulator signaling that the final regulations may arrive in a matter of days or weeks.

The FDA's Janet Woodcock told an industry group that the agency had completed its work on the guidance and expects to release it "promptly," according to a report from BioCentury. And Reuters notes that the FDA has indicated that it has reached a deal with industry reps on the fees that will be charged to finance the regulatory pathway.

An FDA spokesperson tells Reuters that the regulations could arrive in a matter of weeks or days. And no one expects it to be easy.

Just months ago Woodcock and colleagues at the agency sketched out their thoughts on the subject in an article for the New England Journal of Medicine. They made it clear that the "abbreviated" pathway for biosimilars will include demands for animal and human data and ongoing discussions between the regulators and developers as new programs progress.

Once new biosimilars do make it to the market, the big developers in the field say they expect to unleash a marketing campaign quite similar to the way they promote branded biologics. Michael Kamarck, president of Merck BioVentures ($MRK), tells Reuters that the European experience in the field underscores that doctors and patients will look for far more information on biosimilars than they expect for classic generic treatments.

- here's the Reuters story