- The European Medicines Agency (EMA) has accepted Sandoz's application for its biosimilar version of Amgen's Neulasta (pegfilgrastim), which treats some side effects of cancer.
- Sandoz, the generics division of Novartis, is seeking the same indication as Neulasta.
- In November, the FDA accepted Sandoz's biosimilar application for pegfilgrastim through the regulator's 351(k) pathway, setting up future regulatory action in the U.S.
Sandoz has been aggressive on the biosimilar front, particularly against Amgen drugs. In March 2015, Sandoz won the first U.S. biosimilar approval for Zarxio, a copy of Amgen's Neupogen. The FDA is also reviewing Sandoz's application for an Enbrel (Amgen and Pfizer) copy.
The pegfilgrastim application to the EMA is based on three pivotal clinical trials, which Sandoz believes demonstrates its version is sufficiently similar to Neulasta. Demonstrating a high level of similarity enables the biosimilar version to be used in the same indication as the reference product.
Novartis expects low to mid-single digit growth for Sandoz in 2016.
Update: Novartis on Friday announced that Sandoz has acquired the rights to Pfizer's biosimilar infliximab in major European markets. Pfizer's biosimilar is a copy of the blockbuster anti-inflammatory biologic Remicade, which is marketed by Merck in Europe.
When it acquired Hospira in 2015, Pfizer agreed to exit the biosimilar Remicade market in Europe, according to FierceBiotech. However, it is pushing forward in the U.S. with Celltrion as its partner. An FDA advisory committee overwhelmingly recommended approval for their Remicade copy on Tuesday. If approved, their version would be the second biosimilar approved in the U.S.
Sandoz will have development and commercialization rights to biosimilar infliximab in the E.U. plus Liechtenstein, Iceland, and Norway (the European Economic Area).