On February 6, 2025, Dr, Reddy’s Laboratories SA (“Dr. Reddy’s”) announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (“Henlius”) for the development and commercialization of Henlius’s HLX15 (daratumumab), a biosimilar candidate to Janssen’s Darzalex® & Darzalex Faspro®. HLX15 (daratumumab) is a recombinant anti-CD38 fully…
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of SIMPONI®, in the United States. According to the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2506, while…
On February 3, 2025, BioNTech SE (“BioNTech”) confirmed the completion of its acquisition of biotechnology company Biotheus for an upfront payment of $800 million and up to $150 million in potential milestone payments. Biotheus will operate as an indirect Chinese subsidiary of BioNTech. Under the terms of the agreement, BioNTech…
On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI® (eculizumab-aagh), Samsung’s biosimilar of Soliris®, in the United States. According to the agreement, Samsung Bioepis will handle the development, regulatory registration, manufacturing, and supply of the…
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41…
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the brand names PROLIA and XGEVA, is indicated for the treatment of various diseases including osteoporosis…
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). The settlement resolves multiple patent infringement proceedings in the Federal Court of Canada. Under the agreement, Biocon can launch YESAFILI in Canada…
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. As part…
On January 8, 2024, Merck announced its plans to acquire cancer drug developer Harpoon Therapeutics, Inc. for $23.00 per share in cash for an approximate total equity value of $680 million. Harpoon has developed a portfolio of T-cell engagers that employ the company’s Tri-specific T-cell Activating Construct (TriTAC®) platform, an…
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the…