Yesterday, Amneal Pharmaceuticals, Inc. announced the launch of its first biosimilar in the United States: ALYMSYS (bevacizumab-maly), a biosimilar referencing Genentech's AVASTIN product.

On February 22, 2024, Artiva announced that the FDA has granted Fast Track designation to Artiva's AlloNK (AB-101) for the treatment of lupus nephritis in combination with rituximab or obinutuzumab...

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson ("J&J") regarding Bmab 1200, Biocon's proposed biosimilar to STELARA.

On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA.

On February 3, 2025, BioNTech SE ("BioNTech") confirmed the completion of its acquisition of biotechnology company Biotheus...

Celltrion and Genuv Inc., a Seoul-based a clinical-stage biotechnology company focused on drug discovery, entered a partnership last week to develop novel therapeutic antibodies using Genuv's SHINE MOUSE platform.

On October 2, 2025, Celltrion, Inc. ("Celltrion") announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States.

On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that they have entered into a definitive merger agreement, where, at the closing, Coherus...

Beginning tomorrow, July 1, 2023, CYLTEZO® (adalimumab-adbm) will become the first HUMIRA® (adalimumab) biosimilar with interchangeable status to be commercially available in the United States.

On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy's Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar.

Last week, Biocon Biologics Ltd ("BBL") announced that the EMA's Committee for Medicinal Products for Human Use ("CHMP") had issued positive opinions for Biocon's two denosumab biosimilar candidates.

On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that the UK's Medicines and Healthcare product Regulatory Agency (MHRA)...

On March 1, 2024, the Office of Information and Regulatory Affairs ("OIRA"), Office of Management and Budget ("OMB"), Executive Office of the President received the final version of FDA's...

On December 9, 2022, Biogen announced that the FDA has accepted for review an aBLA for BIIB800, Biogen's tocilizumab biosimilar candidate.

On March 18, 2025, Alvotech and Dr. Reddy's announced that the FDA accepted their Biologics Licensing Application (BLA) for AVT03 (denosumab), referencing Amgen's PROLIA® and XGEVA®.

On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane's supplemental Biologics License Application...

On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche's AVASTIN.

Earlier this month, FDA approved Boehringer Ingelheim's high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab).

Johnson & Johnson announced on March 5, 2026 that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv)...

On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis's XOLAIR (omalizumab)