The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. “Merilog ...

A panelist discusses how payer contract requirements and reimbursement policies significantly influence their institution’s biosimilar adoption strategy, requiring careful analysis of net cost ...

We also plan to launch a biosimilar Perjeta in the EU and in Latin America in 2026 with the U.S. following those launches. Lastly, we continue to see further business development opportunities to ...

Biosimilar insulin glargine access in Europe correlates with significant price reductions of originator products, enhancing affordability and accessibility. The study observed a 21.6% average ...

The directors of the Irish arm of pharma giant Roche have stated that there is a need to reduce the lengthy timelines to medicine reimbursement to improve standards of care and outcomes for patients ...

Lerociclib plus fulvestrant demonstrated a progression-free survival (PFS) advantage across all patient subgroups with HR–positive, HER2–negative advanced breast cancer. The selective oral CDK4/6 ...

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA. A biologics license application (BLA) for HLX11, an ...

(“Henlius”) announced FDA acceptance of the Biologics License Application (BLA) for HLX11, a proposed biosimilar to Genentech’s PERJETA. This marks the first U.S. BLA acceptance for a ...

Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.

FDA reviews biologics license application for HLX11, a biosimilar to pertuzumab, for HER2-positive breast cancer. The FDA accepted for review a biologics license application (BLA) seeking the approval ...