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
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Amneal Agrees to Acquire Kashiv BioSciences for Total Payment up to $1.1 Billion
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
Eli Lilly to Acquire Kelonia Therapeutics
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
Sun Pharma to Acquire Organon
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 Regulatory Submission and Deal News
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
Intellia Initiates Rolling BLA Submission for In Vivo CRISPR Therapy in Hereditary Angioedema
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,
Federal Circuit Reverses JMOL and Reinstates Jury Verdict in Teva v. Lilly
On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in a patent dispute between Teva Pharmaceuticals (“Teva”) and Eli Lilly & Co. (“Lilly”). The case stems from a 2018 lawsuit in which
FDA Releases Congressional Justification for FY 2027 Budget, Including Proposal Regarding Interchangeability of Biosimilars
The U.S. Food and Drug Administration (“FDA”) recently released its congressional justification for the 2027 Fiscal Year budget. Overall, the FDA proposed a total budget of $7.2 billion, an overall increase of 3.3% above the 2026 Fiscal Year enacted level.
Biocon Launches Denosumab Biosimilars
On April 7, 2026, Biocon Limited announced that it had launched BOSAYA (denosumab-kyqq) and AUKELSO (denosumab-kyqq) in the United States. Both products are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. BOSAYA and AUKELSO