Report: FDA’s Hamburg says creating biosimilars pathway likely to be complex

NEW YORK To express it in modern parlance, follow-on biologics will be a hot mess.

While speaking at the Reuters Health Summit, according to Reuters, Food and Drug Administration commissioner Margaret Hamburg didn’t put it quite that colorfully, but she had said the science will evolve, meaning a regulatory approval pathway never will be a truly done deal.

The healthcare-reform law requires the FDA to create a regulatory approval pathway for follow-on biologics, also known as biosimilars. Last week, the agency sponsored a hearing to get input from the public that attracted representatives from the branded and generic pharmaceutical and biotech industries, as well as individual companies, such as Teva Pharmaceutical Industries and Sandoz, both of which already make biosimilars for the European market.