This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia. Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen’s STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s…
On March 18, 2025, Alvotech and Dr. Reddy’s announced that the FDA accepted their Biologics Licensing Application (BLA) for AVT03 (denosumab), referencing Amgen’s PROLIA® and XGEVA®. After FDA approval, Alvotech and Dr. Reddy’s expect AVT03 to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL…
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…
The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024. Notably, the committee adopted positive opinions for the following 6 biosimilar products: Samsung Bioepis’s EKSUNBI (ustekinumab), Formycon AG’s FYMSKINA (ustekinumab), and Fresenius…
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…
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy’s Laboratories (“DRL”) and Fresenius Kabi. As we previously reported, Genentech, Hoffmann-La Roche, and Biogen filed a complaint in the U.S. District Court for the District of New Jersey in November 2023, alleging that DRL’s proposed rituximab biosimilar…
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…
Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab)…
On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN (rituximab). RITUXAN is currently FDA-approved for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic…
On March 20, 2023, Coya Therapeutics, Inc. (“Coya”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. COYA 302 is a dual biologic comprised of COYA 301 and…