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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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Xbrane Sets Date For Latest Run At Ranibizumab In US

 
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After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

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The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 
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UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 
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More from Products

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By Dean Rudge

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With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now