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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. link] KBDNA. 2024, May 17). link] Lawless, L.

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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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The role of biosimilars in reducing out-of-pocket costs for patients

Drug Patent Watch

Breaking Down Barriers to Affordable Healthcare: The Power of Biosimilars As we navigate the complex landscape of modern healthcare, one thing is clear: the cost of prescription medications is a significant burden for many patients. So, how do biosimilars work? But the benefits of biosimilars extend far beyond individual patients.

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AbbVie, Coherus mend dispute over low-price Humira biosimilar

BioPharma Drive: Drug Pricing

The biosimilar developer’s plans to set steep discounts on its copycat version of AbbVie’s Humira set off a legal back-and-forth between the companies.

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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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Coherus, sharpening immuno-oncology focus, sells another biosimilar for over $500M

BioPharma Drive: Drug Pricing

The company reached a deal to divest its third biosimilar this year, selling a copycat version of Amgen’s Neulasta for up to $558 million.