Sandoz, the generics arm of Novartis, has acquired from Pfizer the rights for the development and commercialization of an investigational biosimilar of infliximab in the 28 countries that form the European Economic Area (EEA). Pfizer had to divest the European rights to infliximab as part of the European Commission's approval of Pfizer's $17 billion acquisition of Hospira in 2015.

Hospira, now a Pfizer company, entered into a business cooperation agreement with Celltrion in 2009 for several biosimilar products, including a potential biosimilar to Remicade (infliximab). Pfizer has exclusive commercialization rights to the proposed biosimilar infliximab in the US and certain other jurisdictions. This week, a US Food and Drug Administration advisory committee recommended approval of Pfizer's investigational biosimilar of infliximab. Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA. Remicade was the first anti-tumor necrosis factor (TNF)-alpha treatment approved in the United States in August 1998. Janssen Biotech, Inc. part of Johnson & Johnson (J&J), discovered and developed Remicade and markets the product in the United States. In 2015, the product posted global sales of $6.6 billion and US sales of $4.5 billion for J&J. It used to treat a range of autoimmune diseases, including rheumatoid arthritis (RA) and psoriasis.

Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission.

Sandoz has a biosimilar pipeline with programs in various stages of development and regulatory filing, including biosimilars adalimumab and etanercept that, like infliximab, are anti-tumor necrosis factor α (TNF-α) medicines. The company plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the FDA.

In other news, the EMA has accepted the marketing authorization application from Sandoz for its biosimilar to Amgen's EU-licensed 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.

Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. Sandoz's biosimilar version of pegfilgrastim was recently accepted by the FDA for regulatory filing, making it the fifth of 10 biosimilars that the company plans to make over a three-year period (2015-2017).

Source: Sandoz (infliximab) and Sandoz (pegfilgrastim)