On September 22, 2026, Biocon Biologics Limited (“Biocon”) announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending marketing authorization for PEBRILZO® (pertuzumab), its biosimilar to Genentech’s PERJETA®. According to Biocon, PEBRILZO® is the first monoclonal antibody biosimilar to receive…
On August 21, 2026, Alvotech announced a licensing and commercialization agreement with Lotus Pharmaceutical (“Lotus”) for AVT34, a proposed biosimilar to IMFINZI® (durvalumab), and AVT87, a proposed biosimilar to HEMLIBRA® (emicizumab). In the United States, Alvotech and Lotus will have semi-exclusive commercialization rights, with Lotus commercializing through its subsidiary Alvogen….
On August 19, 2026, Ultragenyx Pharmaceutical announced that the FDA granted accelerated approval to its GENGLYCOS™ (pariglasgene brecaparvovec-opnr) for patients eight years and older with glycogen storage disease type Ia (GSDIa). The therapy is approved to reduce daily cornstarch intake as an adjunct to nutritional management. It is the first…
On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that COVID-19 Emergency Use Authorization (EUA) declarations will terminate on December 26, 2026, for medical devices and on June 29, 2027, for drugs and biological products. The declarations were established to facilitate access to unapproved medical…
On June 8, Incyte announced that it has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The transaction would add VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand disease, to Incyte’s hematology portfolio. Under the agreement, Incyte will…
On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema (HAE). Lonvo-z, previously known as NTLA-2002, is designed as a one-time, outpatient-administered treatment using in vivo…
On March 23, 2026, Bio-Thera Solutions announced an expansion of its existing partnership with Intas Pharmaceuticals for BAT2506, its golimumab biosimilar referencing Janssen’s SIMPONI®. The updated agreement grants Intas exclusive commercialization and licensing rights in India and marks Bio-Thera’s first biosimilar commercialization partnership focused on India. Golimumab is a human…
On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals Ltd. FILKRI is indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia (AML)…
As we head into what is anticipated to be a strong year for biopharma dealmaking, we look back at some of the biggest deals in 2025 that focus on biologics and biosimilars. Antibody Therapy Deals Novartis acquires Avidity Biosciences On October 26, 2025, Novartis AG and Avidity Biosciences, Inc. announced…
On November 3, 2025, Samsung Biologics announced the completion of the spin-off of its investment and subsidiary management business unit, and the establishment of Samsung Epis Holdings, an investment holding company that will oversee Samsung Bioepis and other future biotechnology subsidiaries. Samsung Biologics will continue to operate as a pure-play…