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FDA And FTC Offer Advice On Biosimilar Barriers

Workshop On How To Boost Market, From Education To Lawsuits

 
• By Brenda Sandburg

Speakers suggest ways to eliminate barriers to biosimilar uptake, but Janssen pushes back, saying there is need to inform physicians and patients of a biosimilar's interchangeability status. Biosimilar advocates want prescriber incentives, labeling changes, and FDA education on interchangeability.

theater audience watching a performance
FDA/FTC biosimilars workshop draws large crowd • Source: Shutterstock

The biosimilar workshop hosted by the US Food and Drug Administration and the Federal Trade Commission was a sold-out event, drawing a swarm of participants who spilled into an overflow room. While it generated red hot interest among stakeholders, the meeting mostly provided a snapshot of the current biosimilar market with oft-stated recommendations of what could be done to tear down barriers to biosimilar use.

But the 9 March workshop was still a landmark event, illustrating the commitment by FDA and the FTC to take...

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• By Urtė Fultinavičiūtė

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Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By Dave Wallace

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Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By Dave Wallace

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

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• By Dean Rudge

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

Lupin And Zentiva Throw Hat Into The Ring On Biosimilar Cimzia

 
• By Dave Wallace

The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.