AbbVie has submitted a regulatory application to the European Medicines Agency seeking approval for SKYRIZI (risankizumab) subcutaneous induction treatment for adults with moderately to severely active Crohn's disease. The application, supported by positive Phase 3 AFFIRM study data, follows a similar FDA submission and could provide patients with an alternative to intravenous infusion for their induction doses.

The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease...

On January 27, 2025, Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA.

On May 16, 2022, Alvotech Holdings S.A. announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech's proposed biosimilar to STELARA® .

On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review.

Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab), in the United States. AMJEVITA was the first HUMIRA biosimilar approved...

On October 12, Amneal announced that it will be adding two denosumab biosimilars to its oncology pipeline, referencing PROLIA and XGEVA.

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration's ("FDA")...

On July 16, 2025, Bio-Thera Solutions, Ltd. announced that the U.S. Food and Drug Administration had accepted its Biologics License Application for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson's SIMPONI®.

On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia.

Biocon's U.S. subsidiary has secured supplemental FDA approval for YESINTEK® (ustekinumab-kfce) in a new prefilled autoinjector format, expanding delivery options for this biosimilar treatment. The approval covers 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors for treating multiple autoimmune conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris' rights in biosimilars assets for up to $3.3 billion.

On June 2, 2022, Biogen Inc. and Samsung Bioepis Co., Ltd. announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing Genentech's LUCENTIS®, will be available in the United States on July 1, 2022.

On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab...

On March 1, 2023, Biogen Canada Inc. announced that BYOOVIZTM (ranibizumab injection), a biosimilar to Genentech's LUCENTIS, is now available in Canada. BYOOVIZ is an anti-VEGF...

On March 16, 2026, Celltrion, Inc. announced the U.S. commercial launch of AVTOZMA® (tocilizumab-anoh) SC, a subcutaneous formulation of its tocilizumab biosimilar referencing Roche's ACTEMRA.

On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) "who administers pharmacy benefits through its Pharmacy Services...

On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). As we previously reported...

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy...

On April 18, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced plans to roll-out a new approval pathway for rare disease drugs.