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Research and Development › BPCIA

Rothwell, Figg, Ernst & Manbeck, P.C.

Continued Investment in AI Drug Discovery Points to Potential Future Significance of Inventorship in Biosimilar Litigation

Rothwell, Figg, Ernst & Manbeck, P.C. on

On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins. According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA

McDonnell Boehnen Hulbert & Berghoff LLP on

In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more

Foley & Lardner LLP

The PRICED Act Would Expedite Biosimilar Market Entry

Foley & Lardner LLP on

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

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