Novartis acquires European rights to Pfizer's infliximab biosimilar

Novartis' Sandoz unit announced Friday that it gained the European development and marketing rights to Pfizer's PF-06438179, a proposed biosimilar version of Johnson & Johnson and Merck & Co.'s Remicade (infliximab). Richard Francis, global head of Sandoz, remarked that "infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases," adding the unit has agreed to complete Phase III development for PF-06438179 and file for registration in the EU.

According to Sandoz, the development programme includes the late-stage REFLECTIONS trial evaluating PF-06438179 and Remicade in combination with methotrexate in patients with active rheumatoid arthritis who have inadequately responded to methotrexate. Sandoz noted that the deal, whose financial details were not disclosed, follows Pfizer's pledge to the European Commission to divest certain assets, including its proposed Remicade biosimilar, as a condition to acquiring Hospira.

Hospira, whose takeover by Pfizer was completed in September 2015, had launched its own biosimilar version of Remicade early last year under the name Inflectra in a number of European markets. Meanwhile, Pfizer retains marketing and manufacturing rights to PF-06438179 in all countries outside of Europe, Sandoz said.

Earlier this month, an FDA advisory panel supported approval of Celltrion's biosimilar version of Remicade, dubbed CT-P13, for multiple indications, including Crohn's disease, ulcerative colitis and rheumatoid arthritis. Pfizer holds exclusive marketing rights to CT-P13 in the US and certain other jurisdictions following its acquisition of Hospira, which had entered into a partnership with Celltrion in 2009 for several biosimilar products. The Korean drugmaker noted that CT-P13, which if approved in the US will be marketed by Pfizer under the brand Inflectra, is the first biosimilar monoclonal antibody to be reviewed by the FDA.

In addition, the UK's National Institute for Health and Care Excellence recently issued final guidance for severe rheumatoid arthritis that also included Inflectra, as well as Napp Pharmaceuticals' Remicade biosimilar Remsima.

For related analysis, see KOL Views: Celltrion's "fascinating" biosimilar AdCom shows that clinicians can be convinced by the concept of biosimilarity, says leading US regulatory expert Gillian Woollett, and ViewPoints: Extrapolation sensation – FDA panel on board with broad label for Celltrion’s Remicade biosimilar.

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