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…
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…
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. The formulation is intended for pediatric patients (ages 6–17) under 60kg with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, STEQEYMA now matches all dosage…
On January 27, 2025, Alvotech and Teva announced FDA acceptance of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. SIMPONI and SIMPONI ARIA contain golimumab, an anti-TNF therapy for inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This marks the first U.S. BLA acceptance…
On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market…
On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran (nex-z, NTLA-2001), received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in vivo gene editing therapy designed as a single-dose treatment to inactivate…