The European Medicines Agency has approved two ranibizumab biosimilars for treating macular degeneration, while Eli Lilly announced three major acquisitions to expand its infectious disease research. Meanwhile, regulatory approvals continue for biosimilar products including golimumab, denosumab, and insulin glargine, as the FDA issues new guidance on genome-editing safety standards for gene therapy development.

InvaGen Pharmaceuticals Inc., a Cipla Limited subsidiary, has entered into a strategic partnership with Qilu Pharmaceutical Co., Ltd. for the licensing and supply of QL2107, a biosimilar to Merck's KEYTRUDA® (pembrolizumab), in the United States. This collaboration represents the latest in a series of partnering transactions directed to pembrolizumab biosimilar candidates, with Qilu handling development and regulatory registration while Cipla USA manages commercialization.

On March 29, 022, Lannett Company (NYSE: LCI) announced the initiation of its pivotal clinical trial of biosimilar insulin glargine, which is being co-developed with Lannett's strategic alliance partners...

On Jan 9, Coherus BioSciences, Inc. ("Coherus") announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA...

If approved, ranibizumab will be the sixth product approved within STADA´s biosimilar portfolio, joining adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide.

On February 18, 2025, Alvotech and Teva Pharmaceuticals ("Teva") announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application...

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen's RIABNI (rituximab-arrx), a biosimilar to Genentech's RITUXAN®...

On November 8, 2024 Autolus, Inc. ("Autolus") announced that the FDA has approved AUCATZYL (obecabtagene autoleucel) for the treatment of adult patients with relapsed...

On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab). The FDA approved OMLYCLO® with an interchangeability.

On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA...

Regeneron Pharmaceuticals has received FDA approval to extend the dosing intervals for EYLEA HD (aflibercept) in patients with wet age-related macular degeneration and diabetic macular edema.

On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo's ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Orca Bio's TREGZI has received FDA approval as the first precision-engineered cell therapy for matched donor hematopoietic stem cell transplantation in adults with blood cancers. The therapy combines three types of immune cells to reconstitute the immune system and significantly improve chronic graft-versus-host disease-free survival rates. Clinical trial data showed 78% of patients receiving TREGZI achieved higher GVHD-free survival compared to just 38% with conventional transplant methods.

The FDA has approved Regeneron's PASATRU (garetosmab-grts) as the first treatment for fibrodysplasia ossificans progressiva (FOP), an ultra-rare genetic disorder where soft tissue progressively transforms into bone. Clinical trial results demonstrated a 90% or greater reduction in new heterotopic ossification lesions, offering hope for approximately 900 diagnosed patients worldwide suffering from this debilitating condition.

On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment...

On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.'s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech's PERJETA (pertuzumab).

On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm).

On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi)...

As we previously reported, trial in Regeneron Pharmaceutical, Inc.'s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, "the Biocon Defendants")...

On June 29 and 30, 2023, respectively, Formycon AG ("Formycon") and Celltrion Inc. ("Celltrion") announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates.