Novartis’ generic pharmaceuticals division Sandoz has acquired rights of Pfizer’s PF-06438179, a biosimilar of Merck’s Remicade (infliximab), in the European Economic Area (EEA), to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis.
Both the companies have not disclosed the financial terms of the transaction.
As part of the deal, Sandoz aims to complete the clinical study programme, and then undertake regulatory approval with the European Medicines Agency (EMA) and registration with the European Commission (EC).
The clinical programme includes the global Phase III Reflections (B537-02) trial, which is evaluating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in patients with active RA who have had an inadequate response to methotrexate.
Sandoz global head 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."
Sandoz bought the rights to infliximab, after Pfizer agreed to sell the biosimilar infliximab programme in Europe in return for the EC approval of its acquisition of Hospira last year.
It is reported that Pfizer will retain commercialisation and manufacturing rights to infliximab, a tumour necrosis factor alpha (TNF-alpha) inhibitor, in all countries outside the EEA.
The agreement expands Novartis’ immunology portfolio, which includes investigational biosimilars adalimumab, etanercept and rituximab.
Sandoz is committed to increasing patient access to high-quality biosimilars and was the first to launch biosimilars in the US, Europe and Japan.
