FDA And FTC Offer Advice On Biosimilar Barriers
Workshop On How To Boost Market, From Education To Lawsuits
Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.
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Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.
Senate Finance Committee staffer explains Republicans are inclined to support more moderate approaches in the near term as the 'bigger ideas' for promoting biosimilars evolve.
The US FDA has overhauled its ‘Purple Book’ to make it a searchable database of biologics information. The agency is also seeking input on next steps.