
Sandoz buys rights to Pfizer biosimilar
pharmafile | February 12, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Pfiizer, Sandoz, biosimilars
Sandoz has announced further expansion to its biosimilars programme with the acquisition of the European rights to Pfizer’s Remicade (infliximab) biosimilar, known as PF-06438179.
Sandoz said it plans to complete the Phase III clinical study program and submit the biosimilar to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. The program includes the global Phase III REFLECTIONS trial, investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in rheumatoid arthritis (RA) patients who failed to respond to methotrexate alone.
Infliximab, originally developed by Janssen, treats several inflammatory autoimmune diseases in addition to RA, including psoriatic arthritis, chronic plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.
The news caps a busy week for Sandoz’ biosimilars programme. Yesterday, the Novartis company announced the European Medicines Agency had accepted its version of Amgen’s Neulasta (pegfilgrastim), for review. Sandoz plans to make 10 regulatory filings over a three year period (2015-2017).
Earlier this week, an FDA arthritis advisory committee recommended the approval of Celltrion’s Remicade biosimilar, CT-P13, to which Pfizer holds the US commercialisation rights.
Joel Levy
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