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Opinion: Market share isn’t the only metric for biosimilars’ success

STAT

Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. the first biosimilar was launched in September 2015. In the U.S.,

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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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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

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EU Biosimilar Regulatory and Launch Updates

Big Molecule Watch

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizationsforthree biosimilar productsAmgens PAVBLU and SKOJOY, and CuraTeQ Biologics DYRUPEG.

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FDA Approves Ustekinumab, Aflibercept, and Filgrastim Biosimilars

Big Molecule Watch

announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab). According to the press release, PYZCHIVA will be available in the United States beginning on February 22, 2025, pursuant to a settlement and license agreement between Samsung Bioepis and Janssen Biotech Inc.

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Waters, as a strategic partner to the pharma industry, can help India become a world leader in biosimilars

Express Pharma

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025.

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FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar

Big Molecule Watch

On February 18, 2025, Alvotech and Teva Pharmaceuticals (Teva) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to EYLEA 2 milligram (mg). Alvotech is currently developing AVT29, a biosimilar candidate for EYLEA HD 8 mg.