The FDA has granted Breakthrough Therapy designation to Merck calderasib (MK-1084) plus Keytruda for first-line KRAS G12C-mutant NSCLC.

Samsung Bioepis has launched OPUVIZ, its aflibercept biosimilar referencing Eylea, across Europe, marking its fifth directly commercialized biosimilar on the continent and intensifying competition in the $10 billion anti-VEGF market.

Sun Pharmaceutical acquisition of Organon for $11.75B creates one of the world largest biosimilar platforms. For API suppliers, the deal opens new CDMO partnership opportunities across biosimilars and specialty generics.

The FDA's May 15 approval of IMMGOLIS and IMMGOLIS INTRI marks a pivotal expansion in the TNF-alpha inhibitor biosimilar market. For API and intermediate suppliers, this opens new demand channels.