The US FDA should require postmarketing data on what happens when interchangeable biosimilars to the same reference product are substituted for each other, Janssen Biotech Inc. said at a Sept. 4 hearing on promoting competition and innovation in the biologics market.
Prospect Of Biosimilar-To-Biosimilar Switching Spurs Call For Postmarketing Data
US FDA questions innovator push of data to instill confidence that pharmacy-level switching between biosimilars interchangeable with same reference biologic; Janssen and others say agency needs to educate prescribers and pharmacists that an interchangeability designation applies only to a biosimilar and its reference product.
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.
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