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European Commission › Biosimilars › Biotechnology

Goodwin

Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

Goodwin on

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Growing Competition for the World’s Most Profitable Drug as Multiple New Adalimumab Biosimilars Launch

Rothwell, Figg, Ernst & Manbeck, P.C. on

During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20...more

Goodwin

Global Biosimilar Update

Goodwin on

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more

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