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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product.

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First Biosimilar Approved to Treat Multiple Sclerosis

Drugs.com

Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.

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First Biosimilar, Tyruko, Approved to Treat Multiple Sclerosis

Drugs.com

Food and Drug Administration approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection, for the treatment of relapsing forms of multiple sclerosis, the agency announced. FRIDAY, Aug. 25, 2023 -- The U.S.

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CVS launches new venture in biosimilar drug experiment

BioPharma Drive: Drug Pricing

The subsidiary, called Cordavis, will work directly with manufacturers to market or co-produce low-cost biologic drugs, starting with Novartis’ Humira copy.

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Stelara biosimilar from Alvotech, Teva approved by FDA

BioPharma Drive: Drug Pricing

The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.

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Alvotech gets new FDA review for Humira biosimilar

BioPharma Drive: Drug Pricing

The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.

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The impact of biosimilars on biologic drug life cycle management

Drug Patent Watch

The Biosimilar Revolution: How It's Changing the Game for Biologic Drug Manufacturers As the pharmaceutical industry continues to evolve, one trend is gaining significant attention: the rise of biosimilars. In this article, we'll explore the impact of biosimilars on biologic drug life cycle management.