FDA approves trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 21/06/2019 post-comment0 Post your comment

US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its trastuzumab biosimilar Kanjinti (ABP 980).

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Kanjinti (trastuzumab-anns) is a proposed biosimilar to Roche’s Herceptin (trastuzumab), which had worldwide sales of CHF 7.0 billion (US$7.5 billion) in 2017, before the advent of biosimilars [1]. The patents on Herceptin will expire in the US in June 2019 and expired in Europe in July 2014 [2].

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast and gastric cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast and gastric cancers.

Kanjinti has been approved across all eligible indications, namely treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Kanjinti has been approved as a biosimilar, not as an interchangeable product. According to the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), only a biological that has been approved as interchangeable may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

The FDA’s approval of Kanjinti based on a comprehensive totality of evidence which included extensive comparative analytical, pharmacokinetic and clinical data, which, according to Amgen proved Kanjinti ‘to be highly similar to, and to have no clinically meaningful differences from, Herceptin’. In addition, at the time of approval, Kanjinti is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.

The approval of Kanjinti marks the third biosimilar from Amgen to be approved by FDA and the second from the Amgen/Allergan collaboration. Amjevita (adalimumab-atto) was approved in the US in September 2016 [3] and Mvasi (bevacizumab-awwb) was approved in September 2017 [4].

FDA has already approved four other trastuzumab biosimilars. Biocon/Mylan’s Ogivri (trastuzumab-dkst) was approved in December 2017, Celltrion/Teva’s Herzuma (trastuzumab-pkrb) was approved in December 2018, Ontruzant (tratuzumab-dttb) from Samsung Bioepis was approved in January 2019 and Trazimera (trastuzumab-qyyp) was approved in March 2019 [5].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab 
2. Derbyshire M. Patent expiry dates for best-selling biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
3. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar 
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Mvasi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-bevacizumab-biosimilar-Mvasi 
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 21]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US

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Source: Amgen

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