Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.
The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 21 April 2017 [1].
Rixathon has been approved for use in all indications of the originator biological, Roche’s MabThera/Rituxan (rituximab). Rixathon is approved for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukaemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
The approval was based on ‘a comprehensive development program, including analytical, preclinical, and clinical data’, which, according to Sandoz, ‘demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality’.
Clinical studies included:
- The ASSIST-RA study, which demonstrated that Rixathon and its reference medicine have equivalent pharmacokinetic/pharmacodynamic (PK/PD) profiles, with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis.
- The ASSIST-FL study; a phase III confirmatory efficacy and safety study. The study met its primary endpoint of equivalence in overall response rate (ORR) between Rixathon and the reference medicine after six months. Results also confirmed the comparable safety profile of the two medicines.
The approval marks Sandoz’s fourth biosimilar approval in the EU. It received approval for its sompatropin biosimilar (Omnitrope) in April 2006, for its epoetin alfa biosimilar (Binocrit) in August 2007 and for its filgrastim biosimilar (Zarzio) in February 2009 [2]. The company has also received positive opinions from EMA’s CHMP for its etanercept biosimilar (Erelzi) and for another rituximab biosimilar (Riximyo) in April 2017 [1].
The patents on MabThera/Rituxan expired in the US in September 2016 and in Europe in February 2013 [1]. South Korean biotechnology company Celltrion received approval for Truxima (CT‑P10) in February 2017 [3] and received positive opinions from the EMA’s CHMP for Blitzima, Ritemvia and Tuxella in May 2017 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for etanercept and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-etanercept-and-rituximab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for first cancer biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-first-cancer-biosimilar-Truxima
4. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jun 23]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-insulin-and-rituximab-biosimilars
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