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…
Just in December, six companies have announced the launch of their denosumab biosimilars in Europe: Sandoz, Samsung Bioepis, Fresenius Kabi, Zentiva, Biocon Biologics, and Accord. On December 1, 2025: Sandoz launched its denosumab biosimilars, WYOST (120 mg) and JUBBONTI (60 mg) in Europe. WYOST is approved for the treatment of…
Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne). ARMLUPEG is approved as a 6 mg/0.6 mL single-dose prefilled syringe presentation, referencing Amgen’s NEULASTA. ARMLUPEG is indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies who are receiving…
On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. and Amgen Manufacturing Limited (“Amgen”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Gedeon Richter Plc., Gedeon Richter (Schweiz) AG, and Gedeon Richter USA,…
On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (recombinant zoster vaccine) in a prefilled syringe. SHINGRIX combines an antigen (glycoprotein E) with an adjuvant system (AS01B) to protect against…
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and YESINTEK I.V. (ustekinumab for injection, solution for intravenous infusion). YESINTEK and YESINTEK I.V. are biosimilars to Janssen Biotech, Inc.’s STELARA…
On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products and granted provisional interchangeability designations. BOSAYA™ and AUKELSO™ are RANK ligand inhibitors used to treat…
We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. EYLUXVI is a proposed biosimilar to Regeneron’s EYLEA (aflibercept). Alteogen had previously announced clinical results demonstrating similarity between EYLUXVI and EYLEA. On…
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. One of these candidates is SB17, a biosimilar of Janssen’s…
In the past month, President Trump signed two executive orders concerning drug access and affordability, including for biologics and biosimilar drugs. On April 15, 2025, President Trump signed Executive Order No. 14273 (“EO 273”), titled “Lowering Drug Prices By Once Again Putting Americans First.” Then, on May 12, 2025, President…