On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United States for the treatment of KRAS wild-type, epidermal growth factor receptor…
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI are the first biosimilars approved for SIMPONI and SIMPONI ARIA….
On April 21, 2026, Biocon announced that Health Canada granted a Notice of Compliance (NOC) for BOSAYATM (denosumab) and VEVZUOTM (denosumab), biosimilars of Amgen’s Prolia® (denosumab) and Xgeva® (denosumab). Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). In Canada,…
As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement, Samsung received a limited patent license, prohibiting Samsung from sublicensing with…
On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with…
On April 14, 2026, the United States Food and Drug Administration (“FDA”) issued a draft guidance for sponsors seeking approval of human gene-editing therapy products involving gene-editing technologies. The guidance provides recommendations for assessing the safety of genome-editing therapies to bring effective treatments to patients. The guidance includes considerations for…
On April 22, 2026 Amneal Pharmaceuticals, Inc. announced that it entered into an agreement to acquire Kashiv BioSciences, LLC. Under the terms of the agreement, Amneal will pay $375 million in cash and $375 million in equity at closing, along with up to $350 million in additional milestone and other…
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…
AbbVie Submits Regulatory Application to FDA for Subcutaneous SKYRIZI On April 27, 2026, AbbVie announced that it has submitted a regulatory application to the FDA seeking approval for SKYRIZI (risankizumab-rzaa) for subcutaneous induction for the treatment of adult patients with moderately to severely active Crohn’s disease. AbbVie states that its application…