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Regulation

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Industry Alliance Supports Commission On Environment

Off-patent industry association Medicines for Europe is one of several European pharmaceutical associations to have lent their backing to the latest European Commission strategic approach to pharmaceuticals in the environment.

Regulation Europe

Novitium’s Pyridostigmine Shows Six Appeal Of CGT Pathway

In granting its sixth approval for an ANDA with a Competitive Generic Therapy (CGT) designation, the FDA insists it is fostering competition in the US off-patent market.
Approvals Generic Drugs

CREATES Act Will Not Lead To Frivolous Lawsuits, Says AAM's Davis

Association for Accessible Medicines' Davis tries to counter concerns that the long-stalled measure would incentivize lawsuits against brand companies; witnesses at a House subcommittee hearing on drug pricing legislation also testified that the BLOCKING Act would create an overly broad and complicated framework for triggering 180-day exclusivity.

Pricing Debate Generic Drugs

FDA Approves Pfizer's Trastuzumab Biosimilar

Pfizer’s approval for trastuzumab in the US marks the fourth FDA nod for a biosimilar rival to Genentech’s Herceptin original. However, while two of those biosimilar sponsors continue to be engaged in patent litigation with the originator, Pfizer and Mylan have both struck settlement deals.

Biosimilars Regulation

Venipharm Gets European Enoxaparin Nod

Venipharm has received approval for its enoxaparin through the European decentralized procedure. The product was developed in collaboration with China’s Nanjing King-Friend Biochemical Pharmaceutical.

Europe Regulation

FDA Sticks To Its Guns On Biosimilar Naming

In the face of calls from the biosimilars industry to rethink its position on biological naming conventions as being out of step with other major territories, the FDA has issued fresh guidance that reinforces its commitment to using four-letter suffixes for both biosimilars and new brand biologics, as well as confirming that the names of any biosimilars designated as ‘interchangeable’ will bear a suffix. At the same time, the agency has rowed back on previous proposals to retroactively add a suffix to already-licensed biologics.

Regulation Biosimilars
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