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FDA’s recently released draft guidance on interchangeability considerations discusses how differences in product presentation between a biosimilar and...
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A webpage for PharmaTher’s ketamine product lacked risk information and made misleading claims about the approved indication, the FDA said in a rare ad/promo violation letter to an ANDA holder.
The US FDA delivered its promise to publish product-specific guidances in November, after two late batches earlier this year. Third time might have been a charm, but it remains to be seen if the December batch will be the fourth time guaranteed.
Generics Bulletin reviews global regulatory developments across the world.
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
After 10 years of adding suffixes to all new biologic and biosimilar nonproprietary names, FDA officials are considering whether it is still necessary for pharmacovigilance purposes.
Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.
Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.
