Sandoz acquires European rights to Pfizer’s infliximab biosimilar

The companies did not disclose the financial terms of the transaction. Pfizer will retain commercialization and manufacturing rights to infliximab in all countries outside the EEA.

Sandoz aims to complete the clinical study program, then undertake regulatory approval with the European Medicines Agency (EMA) and registration with the European Commission (EC).

The clinical program includes the global phase III Reflections (B537-02) trial, which will compare the safety and efficacy of PF-06438179 with the combination of infliximab and methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate.

The agreement expands Novartis immunology portfolio which includes investigational biosimilars adalimumab, etanercept and rituximab.

Pfizer agreed to sell the biosimilar infliximab program in Europe in return for the EC approval of its acquisition of Hospira last year.

Sandoz division head and CEO Richard Francis said: "Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis.

"We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments."

Last week, the EMA accepted an application to review Sandoz’s biosimilar to Amgen’s EU-licensed Neulasta (pegfilgrastim) cancer drug.

Sandoz is seeking approval for the similar indication as the reference product.

Image: Novartis headquarters in Basel. Photo: courteys of –Andrew- from Flickr.