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Prospect Of Biosimilar-To-Biosimilar Switching Spurs Call For Postmarketing Data

 
• By Sue Sutter

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.

Rail switches in yard off mainline
The potential for patients to be switched back and forth between biosimilars has innovators calling for FDA action.

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.

Such data are needed to instill confidence in prescribers that patients who experience pharmacy-level switching between biosimilars that are interchangeable with a common reference biologic, but not each other, will not suffer adverse effects resulting from subtle differences between the biosimilars, said Andrew Greenspan, vice

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