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When Drugs Become Biologics: US FDA Guidances Explain 'Transition Provisions'

 
• By Sue Sutter

With two new guidance documents, agency is trying to bring order to the potentially chaotic regulatory process that insulins and other currently approved protein products will face in March 2020; FDA also issues two more Q&A guidance documents on scientific and regulatory considerations for biosimilars.

The concept of order and chaos. Chaotic disorganized colorful paper clips and to order the yellow paper clip

With a raft of new guidance documents, the US FDA is trying to instill order in the potentially chaotic process that some currently approved protein products will face in March 2020, while also clarifying the requirements for bringing new biosimilar products to market.

The agency released four guidance documents Dec. 11 under its Biosimilars Action Plan. FDA Commissioner Scott Gottlieb discussed the guidances...

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

More from Biosimilars & Generics

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By Dean Rudge

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

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.