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Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars

 
• By Derrick Gingery

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Steps
The approach is not working from a 'chronological' standpoint, Sarah Yim said. • Source: Shutterstock

After more than a decade, the US FDA’s vaunted step-wise approach to biosimilar development is not being used as intended, which may be hindering the sector’s growth and limiting pricing pressure on originator biologics.

The FDA wants biosimilar sponsors to analytically characterize their biosimilar candidates before conducting clinical trials, which can help eliminate uncertainty...

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More from Biosimilars

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 
• By Urtė Fultinavičiūtė

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

 
• By Dean Rudge

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

Alvotech Boosts Packaging Abilities With Ivers-Lee Acquisition

 
• By Dean Rudge

Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.

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.

More from Products

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.

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

 
• 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.