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Interchangeability: FDA Sets ‘Stringent’ Standard On Design Differences

 
• By Sue Sutter

Sponsors must assess any differences in a biosimilar’s container closure system or delivery device relative to the US reference product and may need to conduct comparative use human factor studies to ensure there is no increased risk of use-related error with the biosimilar.

The US FDA has shown a willingness to license biosimilars with container closure systems or delivery devices that differ from the reference biologic, but interchangeability determinations may be harder to come by for such products.

FDA’s recently released draft guidance on interchangeability considerations discusses how differences in product presentation between a biosimilar and...

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More from Policy & Regulation

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• By Urtė Fultinavičiūtė

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

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Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
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