Sandoz Picks Up Pfizer's Infliximab Biosimilar
This article was originally published in Scrip
Novartis AG's generics business Sandoz is bulking up its budding biosimilars portfolio by acquiring the rights to Pfizer Inc.'s PF-06438179, a biosimilar version of infliximab (Johnson and Johnson's Remicade), in Europe.
Pfizer was ordered to divest the product as one of the conditions set by the European Commission before it would allow the pharma giant's $17bn acquisition of biosimilar specialist Hospira Inc. toproceed. Infliximab is a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.
The biosimilar product is currently in Phase III trials for rheumatoid arthritis and under the terms of the deal, for which financial details were not disclosed, Sandoz plans to complete the clinical study program and submit the biosimilar to the European Medicines Agency (EMA) for regulatory approval.
Sandoz said the company would be seeking extrapolation for all indications when it submits the product for approval in Europe as this is the "central element" of Sandoz's biosimilar development strategy.
Sandoz added, "The addition of biosimilar infliximab strengthens our pipeline which includes biosimilars of adalimumab and etanercept that, like infliximab, are TNF-alpha inhibitors."
Pfizer will retain commercialization and manufacturing rights to infliximab in all countries outside of the 28 countries that form the European Economic Area. The European Commission imposed the divesture of Pfizer's biosimilar infliximab product because the authority was concerned Pfizer might either delay or discontinue development of this product to focus on Hospira's version, which is already on the market.
Sandoz has been working for more than a decade in biosimilar development and has a leading pipeline with several products at late stages of development. The company plans to make 10 regulatory filings in a three year period from 2015-2017 and has already announced five filings. The company said it is focused on biosimilar development because the products "foster competition in an area that has historically been unhealthily short of it."