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FDA’s Burden Estimate On Biologic Naming Ignores Downstream Costs, Critics Say

 
• By Sue Sutter

Costs across the US healthcare system of implementing new suffix-based nomenclature could reach into the billions, stakeholders say in requesting the Office of Management and Budget delay implementation of FDA’s final guidance on nonproprietary naming of biologics pending further analysis.

Complaints that the US FDA’s burden estimates for implementing a suffix-based nonproprietary naming system for all biologic products failed to take into account hundreds of millions of dollars in downstream costs may find a receptive audience in the Trump Administration.

Several stakeholders have requested the Office of Management and Budget (OMB) delay implementation of the suffix-based naming policy outlined in...

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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.