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Patent Litigation License Agreements Food and Drug Administration (FDA)

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

Goodwin on

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Venable LLP

Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506

Venable LLP on

On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab).  ...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2019

Robins Kaplan LLP on

Please see Chart below for more information....more

McDermott Will & Emery

Combining Two Drugs Is Not Always Obvious

Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. - Addressing the obviousness of combining two known hypertension medications, the U.S. Court of Appeals for the Federal Circuit upheld a ruling of...more

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