Biosimilars
Page 1 • 11 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 Enters Diabetes Market
FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.
Teva Reports Strong Q1 2026 Results as PONLIMSI Biosimilar Receives FDA Approval and Olanzapine LAI Advances
Teva's Q1 2026 earnings show strong performance driven by PONLIMSI biosimilar FDA approval and olanzapine LAI NDA acceptance for schizophrenia treatment.
Teva's PONLIMSI Biosimilar Receives FDA Approval for All Prolia Indications as Q1 2026 Results Show Strong Growth
Teva's PONLIMSI biosimilar gains FDA approval for all Prolia indications while duvakitug shows promising Phase 2b results in inflammatory bowel disease.
Outlook Therapeutics Completes FDA Dispute Resolution Meeting for LYTENAVA Bevacizumab Biosimilar
Outlook Therapeutics completed Federal Dispute Resolution meeting with FDA for ONS-5010/LYTENAVA bevacizumab-vikg retinal disease treatment regulatory pathway.
FDA Biosimilar Substitution Policy Update: Key Regulatory Changes
The FDA's recent biosimilar substitution policy update introduces significant regulatory changes affecting Humira's use in rheumatoid arthritis treatment.
FDA Approves Riabni Biosimilar: Expanding NHL Treatment Options
The FDA's approval of Riabni as a biosimilar for non-Hodgkin lymphoma (NHL) marks a significant advancement in treatment options for patients.
FDA Approves BioClone's Clone-Remicade: Cheaper Alternative to Remicade
BioClone's Clone-Remicade has received FDA approval, offering a more affordable option for patients requiring treatment for autoimmune diseases, similar to Remicade.
FDA Approves Biosimilar Insulin Lispro: What You Need to Know
The FDA has approved a biosimilar version of insulin lispro, offering a new option for diabetes management and potentially lowering treatment costs.
FDA Priority Review Granted to CardioGen's RevivCor for Heart Failure
CardioGen's RevivCor has received FDA Priority Review status for heart failure, signaling a potential breakthrough in treatment options for patients.
FDA Approves First Interchangeable Biosimilar for Stelara (Ustekinumab)
The FDA has approved the first interchangeable biosimilar for Stelara (Ustekinumab), expanding treatment options for patients with psoriasis and Crohn's disease.
FDA Approves First Interchangeable Humira Biosimilar: Key Details
The FDA has approved the first interchangeable biosimilar to Humira, a significant milestone for patients with autoimmune conditions seeking affordable treatment alternatives.