On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection.

On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen's STELARA. STEQEYMA is approved for subcutaneous injection.

On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine ("RSV"), mRESVIA (mRNA-1345).

Samsung Bioepis ("Samsung") announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion's SOLIRIS. EPYSQLI has been approved for the treatment of patients...

On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO).

On September 20, Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review status to Merck's supplemental Biologics License Application (sBLA)...

On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA...

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22...

Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson ("J&J") in the United States relating to SB17, Samsung Bioepis's ustekinumab...

On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.

On August 30, 2022, Outlook Therapeutics, Inc. announced that it has re-submitted its Biologics License Application (BLA) to the FDA for ONS-5010, "an investigational ophthalmic therapy...

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar...

Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab).

On March 21, 2023, Sandoz, announced FDA approval of its citrate-free high-concentration formulation (HCF) of its biosimilar HYRIMOZ® (adalimumab-adaz) injection.

On May 31, 2022, Sandoz announced the launch of a new global initiative called "Act4Biosimilars" to help address health inequity and inequality worldwide.

On October 20, 2025, Teva Pharmaceuticals International GmbH ("Teva") announced a licensing agreement with Prestige BioPharma Ltd. ("Prestige BioPharma") to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech's HERCEPTIN (trastuzumab), in a majority of European countries.

On December 6, 2025, Vertex Pharmaceuticals Inc. ("Vertex") announced data from several studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel)...

On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc.

Many in the crypto industry have been calling for clear guidance from government regulators, especially as new sectors like DeFi evolve and high-profile companies collapse.

On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil's bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year...