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

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