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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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How GPCR-targeting therapies are advancing the fight against inflammatory disease

Drug Target Review

All these features make GPCRs central to regulating many vital biological processes in the body, including immune responses and inflammation, and thus especially attractive for therapeutic intervention. It also holds potential for neuroinflammatory conditions such as certain types of migraine.

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The Issue with Reissue: PTE Edition

FDA Law Blog: Biosimilars

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. If a compliance or quality program exists only as bargaining chip to use with regulators, thats not a formula to instill good habits.

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Pharma Contract Sales Outlook 2025–2030: Multilingual Teams Drive Global Expansion

The Pharma Data

As pharma companies grapple with mounting pressure from regulators, payers, and evolving market dynamics, the CSO model offers a compelling alternative to traditional, fully in-house sales forces. These markets are characterized by stringent pricing regulations and decentralized healthcare systems, making localized sales expertise essential.

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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? By Richard A.

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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert & Lisa M. The DCP should follow applicable regulations governing human subject protections, where applicable. By Adrienne R. Some disease conditions may not be as prevalent and the DCP should describe any enrichment strategies to ensure subgroups are represented.

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