3,4 So what are biosimilars? They are biologic medicines that are highly similar to existing licensed biologic products (often referred to as reference or innovator products) with no clinically ...

What will be important about biosimilars market penetration will be such rules that really push prescribers and payers to go for lower priced products compared with originator products.

Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of ...

FDA has approved a grand total of 63 biosimilars across 17 unique reference products, with many biosimilar products competing against the same reference product.

After approval by the FDA, AVT03 is expected to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 ml ...

“The FDA has now approved three biosimilar insulin products to treat diabetes,” noted Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.

1. The Department of Health has confirmed that a remit referred to NICE enables NICE to decide to apply the same remit, and resulting guidance, to relevant licensed biosimilar products which ...

Aurobindo, that last year signed a deal with U.S. drugmaker MSD to manufacture one of their biologics products at its subsidiary Theranym Biologics, has agreed on a contract to roll out a single ...

LAKE ZURICH, IL, USA I March 27, 2025 I Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® ...

Comparable efficacy results were observed at week 78 after switching to the biosimilar from the reference product (secondary endpoint). Safety, pharmacokinetic, and immunogenicity data demonstrated ...

Alvotech acquires Xbrane’s R&D operations and the biosimilar candidate XB003. Xbrane retains some pre-clinical development programs, that it intends to commercialize, and will continue operating as a ...