On April 20, 2026, Eli Lilly & Company (“Lilly”) and Kelonia Therapeutics, Inc. (“Kelonia”) announced an agreement for Lilly to acquire Kelonia in an all-cash transaction expected to close in the second half of 2026. Under the terms of the agreement, Kelonia shareholders will receive an upfront payment of $3.25…
On April 26, 2026, Sun Pharmaceutical Industries Limited (“Sun Pharma”) and Organon & Co. (“Organon”) announced an agreement for Sun Pharma to acquire all outstanding shares of Organon in an all-cash transaction valued at $11.75 billion and expected to close in early 2027. Organon will merge with a subsidiary of…
On March 20, 2026, Accord BioPharma, Inc. (“Accord”), Intas Pharmaceuticals Ltd. (“Intas”), and Bio-Thera Solutions, Ltd. (“Bio-Thera,” collectively “Petitioners”) filed four Inter Partes Review petitions (“IPRs”) challenging four patents directed to methods of treatment using golimumab. The four patents are owned by Janssen Biotech, Inc. (“Janssen”), a subsidiary of Johnson &…
On February 10, 2026, the World Health Organization (“WHO”) prequalified a new novel oral polio vaccine type 2 (“nOPV2”) product. The newly prequalified product will be manufactured by Biological E. Limited, India using in-house bulk vaccine technology transferred from PT Bio Farma (Persero), Indonesia. WHO has previously prequalified nOPV2 products…
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…
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Guidance…
On November 6, 2025, Amgen, Inc. (“Amgen”) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy’s Laboratories (“Dr. Reddy’s”) and Alvotech, and the second against Amneal Pharmaceuticals (“Amneal”). As we previously…
On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (“Biogen”) to pay Genentech, Inc. (“Genentech”) $88,348,123 in unpaid royalties plus interest. The parties stipulated to $35,903,701 in interest on October 3. As we reported previously, in 2004, Genentech granted a non-exclusive…
On September 18 and 19, 2025, the Patent Trial and Appeals Board (“PTAB”) issued final written decisions for four inter partes review (“IPR”) challenges brought by Merck Sharp & Dohme LLC (“Merck”) against Johns Hopkins University’s (“Johns Hopkins”) pembrolizumab patents, finding that all claims were unpatentable. The dispute between Merck…
On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Samsung Bioepis Co., Ltd. and Samsung Biologics Co., Ltd. (“Samsung”), one day after Amgen and Samsung executed a Confidential Settlement…