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European Biosimilar Regulatory Update

In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more

Alvotech Announces Positive Topline Results From Confirmatory Clinical Study for its Proposed Golimumab Biosimilar

On April 23, 2024, Alvotech announced “positive topline results from a confirmatory clinical study for AVT05,” Alvotech’s proposed golimumab biosimilar to Janssen Biotech, Inc.’s SIMPONI(R) and SIMPONI ARIA(R).  According to...more

Ustekinumab Antitrust Litigation

On December 7, 2023, a group of health insurers and health insurance administrators filed a class action complaint against Johnson & Johnson and Janssen Biotech, Inc. (collectively “J&J”) in the Eastern District of Virginia...more

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