Consider what Steve Usdin of BioCentury has to say on the subject of biosimilars in the wake of the recent Federal Trade Commission (FTC) report.
“A Federal Trade Commission (FTC) report released last week, and the responses to it from members of Congress and industry, demonstrate that the prolonged debate has not diminished the controversy over the best ways to balance incentives for biomedical innovation with the economic benefits to patients and payers that could be produced by a robust biosimilars market.
The FTC flatly rejected arguments the Biotechnology Industry Organization (BIO) has made to justify its contention that a 14-year exclusivity period for pioneer biologic products is essential to ensure the future ability of companies to attract capital and to invest in new product development.
Indeed, all four FTC commissioners signed off on the report, “Emerging Health Care Issues: Follow-on Biologic Drug Competition,” which argues there is no need for any market exclusivity for pioneer biologics beyond that provided by patents, save for products for Orphan diseases and unpatentable drugs.”
Ouch.
According to the FTC, “There is no evidence that patents claiming a biologic drug product have been designed around more frequently than those claiming small molecule products.”
Double ouch.
Usdin’s complete article is worth a careful read.
Suffering from the seven-year itch?