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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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Transparency Shocker: Biosimilars Are Getting Cheaper—But Hospitals and Insurers Can Make Them Expensive

Drug Channels

Here on Drug Channels , we have long highlighted the boom in provider-administered biosimilars. In contrast to the pharmacy market, adoption of these biosimilars is growing, prices are dropping, and formulary barriers continue to fall. As we demonstrate, health plans pay hospitals far above acquisition costs for biosimilars.

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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.