Novartis group Sandoz has acquired rights to Pfizer’s PF-06438179, a biosimilar of MSD’s Remicade (infliximab), in the 28 countries that form the European Economic Area (EEA), further strengthening its immunology offering.
Financial terms of the deal weren’t disclosed, but Sandoz said it intends to complete the ongoing Phase III clinical study programme and submit the drug to the European Medicines Agency for regulatory approval.
"Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis" said Richard Francis, Global Head of Sandoz, explaining his interest in the deal.
From Pfizer's side, the move falls in line with its commitments to the European Commission in connection with its acquisition of Hospira to divest the programme, and it retains rights to the biosimilar in all countries outside of the EEA .
In Europe, Hospira UK and Napp Pharmaceuticals both market Celltrion’s biosimliar version of the drug under the brand names Inflectra and Remsima, respectively.
Neulasta biosimilar under review
The deal came hot on the heels of news that the EMA has accepted Sandoz’ marketing application for its biosimilar to Amgen's Neulasta (pegfilgrastim), a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF).
Sandoz is seeking approval for the same indication as the reference product, which is used in cancer patients (except those with chronic myeloid leukaemia and myelodysplastic syndromes) to help with some of the side effects of treatment.
The drug reduces the duration of neutropaenia (low levels of neutrophils, a type of white blood cell that fights infections) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemotherapy treatment.