Sandoz advances biosimilars pipeline

Biosimilars/News | Posted 09/05/2014 post-comment0 Post your comment

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 28 April 2014 that it had reached several important milestones in the development of biosimilar etanercept, filgrastim and pegfilgrastim.

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Patient enrolment has been completed for its phase III trial with biosimilar etanercept (EGALITY). The aim of the trial is to demonstrate the equivalent efficacy of Sandoz’s biosimilar etanercept (GP2015) and Amgen’s Enbrel in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12. The randomized, double-blind, multicentre study is being carried out in Bulgaria, Czech Republic, Estonia, Germany, Hungary, Poland, Romania, Russia, Slovakia, South Africa, Ukraine and UK, with an estimated enrolment of 546 psoriasis patients.

A phase III trial (PIONEER) comparing biosimilar filgrastim to Amgen’s Neupogen in breast cancer patients eligible for myelosuppresive chemotherapy treatment has been completed. The trial was carried out in Czech Republic, Estonia, Germany, Hungary, Latvia, Russia and Slovakia, and included approximately 218 women with histologically proven breast cancer. Sandoz intends to use the results of this trial for the US registration of its filgrastim biosimilar (EP2006) and is currently preparing to file biosimilar filgrastim in the US.

Two global phase III trials (PROTECT 1 & 2) comparing biosimilar pegfilgrastim to Amgen’s Neulasta in breast cancer patients eligible for myelosuppresive chemotherapy treatment have also been completed. The trials will be used to support the registration of biosimilar pegfilgrastim in the US and the European Union.

The company currently has six molecules in the phase III clinical trial or in the filing preparation phase. Biosimilars under development include biosimilar versions of Roche’s Rituxan/MabThera (rituximab) and AbbVie’s Humira (adalimumab) [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III biosimilar adalimumab trial []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from:

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Source:, EU Clinical Trials Register, Sandoz

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