Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets

Shilpa Biologicals and SteinCares ink strategic pact to bring biosimilars to Latin America

New partnership combines Shilpa Biologicals’ development and manufacturing capabilities with SteinCares’ regional commercialization platform

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar

BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data

Lupin receives European Commission approval for biosimilar Ranibizumab

Biocon posts strong Q3FY26 growth, boosted by biosimilars & generics

Profit before tax jumped 64% to Rs. 226 crore, while the company maintained robust investment in innovation with net R&D spend of Rs. 249 crore

Zydus launches world’s first biosimilar of Nivolumab in India, cutting costs by 75%

Biocon Biologics to introduce three new oncology biosimilars, eyes $75 billion market opportunity

The new assets expand Biocon Biologics’ already robust oncology portfolio, which now includes 17 cancer therapies

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Biocon Biologics expands FKB deal to secure global rights for Adalimumab biosimilar

Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized

Alvotech, Teva secure US settlement with Regeneron for Eylea biosimilar launch

Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026