FDA rejects trastuzumab and rituximab biosimilars Posted 04/05/2018

US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.

Pfizer received a Complete Response Letter (CRL) regarding the company’s Biologics License Application (BLA) for its trastuzumab biosimilar. In the CRL, says Pfizer, FDA highlighted the need for additional technical information. However, Pfizer points out that ‘the additional requested information does not relate to safety or clinical data submitted in the application’.

Pfizer submitted its applications for its proposed trastuzumab biosimilar (PF‑05280014) to the European Medicines Agency (EMA) and to FDA for approval in September 2017 [1]. The company says it is ‘working closely with the FDA to address the contents of the letter and remains committed to bringing this important medicine to patients in the US’.

Sandoz also received a CRL regarding the company’s BLA for its proposed biosimilar rituximab. Although there were no details, the company says it ‘stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter’.

Sandoz’s rituximab biosimilar Rixathon/Riximyo (GP2013) was approved by the European Commission (EC) in June 2017 [2] and was accepted for review by FDA in September 2017 [3]. The company says that although it is disappointed, it ‘remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible’.

These latest rejections follow the agency’s rejection of Celltrion/Teva’s biosimilar rituximab and trastuzumab applications earlier in April 2018 [4].

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References
1.  GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Pfizer’s trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Pfizer-s-trastuzumab-biosimilar
2.  GaBI Online - Generics and Biosimilars Initiative. EC approval for rituximab biosimilar Rixathon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-rituximab-biosimilar-Rixathon
3.  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 May 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-rituximab-biosimilar-from-Sandoz
4.  GaBI Online - Generics and Biosimilars Initiative. FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars

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Source: Pfizer, Sandoz

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