Biosimilars
Page 1 • 7 itemsTrack global biosimilar approvals, market entry strategies, and regulatory pathways. Gain critical intelligence for your pharmaceutical BD and investment decisions.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Receives Key Diabetes Drug Approval
FDA approves LANGLARA (insulin glargine-aldy) as interchangeable biosimilar to Lantus for diabetes treatment in adults and pediatric patients.
European Commission Approves POHERDY, First Pertuzumab Biosimilar in Europe by Henlius and Organon
EC grants marketing authorization for POHERDY (pertuzumab), the first approved biosimilar to PERJETA in Europe, developed by Henlius Biotech and Organon.
Henlius and Organon's POHERDY Becomes First Pertuzumab Biosimilar Approved in Europe
European Commission approves POHERDY as first pertuzumab biosimilar in Europe, offering cost-effective alternative to PERJETA for breast cancer treatment.
Biocon Receives Health Canada Approval for Denosumab Biosimilars Bosaya and Vevzuo
Health Canada approves Biocon's denosumab biosimilars Bosaya and Vevzuo as alternatives to Prolia and Xgeva for osteoporosis and cancer treatment.
Cigna Healthcare Adds Accord BioPharma's IMULDOSA Biosimilar to Preferred Coverage Plans
Cigna Healthcare now covers IMULDOSA (ustekinumab-srlf), Accord BioPharma's biosimilar to STELARA, under commercial plans effective April 15, 2026.
EMA Biosimilar Policy: Market Impact and Regulatory Insights 2024
This article delves into the EMA's 2024 biosimilar policy, analyzing its market impact and regulatory insights for biologics such as adalimumab.
Denosumab Biosimilar Authorization by EMA: Key Details
The EMA has authorized Denosumab biosimilars, marking a significant advancement in osteoporosis treatment and improving patient access to effective therapies.