1. Pink Sheet

That’s So 15 Years Ago: Biosimilar Advocates Press US FDA, Sponsors To Evolve Thinking, Streamline Development

 
• By Derrick Gingery

Requirements should adjust to scientific advancement, rather than remain rooted in times when the FDA and sponsors were inexperienced dealing with the products, sponsors argue.

evolution
Biosimilar sponsors want the FDA and industry to update their thinking to encompass current science and experience. • Source: Shutterstock

Biosimilar sponsors are being bogged down by unnecessary and repetitive studies, which may be limiting investment in the teenaged US sector.

The Biosimilars Forum, a trade association of biosimilar sponsors, wants the US Food and Drug Administration and industry to embrace a more streamlined approach to product development. Unfortunately, despite being...

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