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
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
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,
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
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
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
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
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
On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema (HAE). Lonvo-z, previously known as NTLA-2002,
