Can Samsung Bioepis challenge Keytruda after its U.S. patent cliff begins in 2028?
Samsung Bioepis matched Keytruda in Phase 3, but an earlier FDA filing and Keytruda Qlex complicate the coming biosimilar battle.
Features & Analysis
Pharma & Biotech
Zydus gains regulatory milestone in $31.7bn Keytruda biosimilar market
The FDA has accepted FYB206, a proposed biosimilar to Merck's Keytruda, for review, with a decision potentially due in the third quarter of 2027. Zydus and Formycon pursued a streamlined development programme without a comparative Phase 3 efficacy trial, but approval, patent clearance and commercial launch remain separate hurdles.
Pharma & Biotech
Can Zydus saroglitazar compete with Iqirvo and Livdelzi in the US PBC market?
Zydus saroglitazar shows 60.7% US biochemical response in PBC as its November 27 FDA decision approaches. Examine the Phase 3 evidence.
Pharma & Biotech
Zydus Lifesciences’ Assertio merger signals a bigger push beyond generics into U.S. oncology
Find out how Zydus Lifesciences’ Assertio merger could reshape its U.S. oncology supportive-care strategy and Rolvedon growth.
Pharma & Biotech
Zydus gains FDA Priority Review for saroglitazar as PBC treatment competition intensifies
Zydus’ saroglitazar gets FDA Priority Review in PBC, setting up a key test for dual PPAR therapy in rare liver disease.