Sandoz Group AG

Biocon Ltd. is seeking regulatory approval for generic versions of Novo Nordisk's Ozempic and Wegovy, targeting Canada as its first major market entry by 2026.

Bio-Thera Solutions has dosed the first patient in a pivotal phase 3 trial for BAT8006, an antibody-drug conjugate targeting folate receptor α for platinum-resistant ovarian cancer treatment.

Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements.

Health Canada has released draft guidance that would eliminate the requirement for comparative Phase III clinical trials in biosimilar drug approvals, marking a significant policy reversal.

Novo Nordisk permanently forfeited Canadian patent protection for semaglutide after failing to pay a routine $450 maintenance fee in 2019, clearing the path for generic competitors.

The three largest U.S. pharmacy benefit managers have excluded nearly all marketed Humira biosimilars from their 2025 standard formularies, marking a dramatic shift from 2024 when eight products were covered.

Sandoz has launched WYOST® and Jubbonti®, the first and only FDA-approved interchangeable denosumab biosimilars in the United States, providing cost-effective alternatives to reference medicines XGEVA® and Prolia®.

Esperion Therapeutics has reached a settlement agreement with Micro Labs that prevents the generic manufacturer from marketing a version of NEXLETOL (bempedoic acid) before April 19, 2040.

Cimerli (ranibizumab-eqrn), developed by Sandoz, is the first and only FDA-approved interchangeable biosimilar to Lucentis for treating various ocular conditions including neovascular age-related macular degeneration.

Henlius has granted Sandoz exclusive commercialization rights for its ipilimumab biosimilar HLX13 across major markets including North America, Europe, Japan, and Australia.