Novartis, announced on 2 November 2018 that its generics division, Sandoz, would no longer pursue approval for its rituximab biosimilar in the US ‘at this time’.

Sandoz had its application for approval for its proposed rituximab biosimilar (GP2013) accepted by the US Food and Drug Administration (FDA) in September 2017 [1]. The decision to not pursue the application further follows a request by the agency for additional information to complement the submission [2].

Sandoz’s rituximab biosimilar Rixathon/Riximyo (GP2013) was approved by the European Commission (EC) in June 2017 [3]. In addition, it has also gained approval for GP2013 in Australia [4], Japan, New Zealand and Switzerland.

Although Sandoz says that it is ‘disappointed to have to make this decision’, it still ‘stands behind the safety, efficacy and quality’ of its rituximab biosimilar, which it points out ‘met the stringent criteria for approval in the European Union, Switzerland, Japan, New Zealand and Australia’. The company says that it will now ‘focus on opportunities in the US and around the world’ where it can ‘best meet rapidly evolving patient and healthcare system needs’.

Germany-based Boehringer Ingelheim (Boehringer), to the contrary, has said that it will not commercialize its approved adalimumab biosimilar Cyltezo (BI 695501) in Europe and is discontinuing all biosimilar development activities outside the US.

Boehringer received FDA approval for Cyltezo (adalimumab-adbm) (BI 695501) in August 2017 [5] and European approval in November 2018 [6]. The company is also working on a bevacizumab biosimilar (BI 695502), the phase III trial for which is expected to be completed in March 2019 [7].

According to spokesperson Ralph Warsinsky, Boehringer ‘believes the introduction of high quality, lower-cost biosimilars is critical for both patients and the sustainability of the healthcare system’. However, he added that ‘at this point in time, future biosimilars activities will be driven out of the US market, including partnership opportunities’. The company is therefore ‘stopping development activities for the rest of the world’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for rituximab biosimilar from Sandoz [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-rituximab-biosimilar-from-Sandoz
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects trastuzumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-trastuzumab-and-rituximab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for rituximab biosimilar Rixathon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-rituximab-biosimilar-Rixathon
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Cyltezo
6. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Cyltezo [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Cyltezo
7. GaBI Online - Generics and Biosimilars Initiative. Pivotal clinical trials for bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Reports/Pivotal-clinical-trials-for-bevacizumab-biosimilars

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