Are we on the verge of a biosimilars breakthrough in the USA?

A total of 32 biosimilar products, based on 12 biologics, have been approved for use in the European Union. This compares with just 10 in the USA, referencing nine biologics.

European regulators have been quick to embrace biosimilars, and the promise of lower cost access to cutting edge medical technologies, with the establishment of a special regulatory route for follow-on biologics, termed "similar biological medicinal products.”

Whereas Europe got its first biosimilar in 2006, with EU approval for Sandoz’s rare disease product Omnitrope (somatropin), the US Food and Drug Administration wasn’t able to approve a biosimilar until nearly a decade later, with Zarxio (filgrastim-sndz), also from the Novartis (NOVN: VX) subsidiary Sandoz.