Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.
Amgen and its partner Allergan announced that the application for their proposed trastuzumab biosimilar (ABP 980) had been accepted by FDA in July 2017 [1]. ABP 980 is a proposed biosimilar of Roche’s breast and gastrointestinal cancer treatment Herceptin (trastuzumab), which had 2017 worldwide sales of CHF 7.0 billion (US$7.5 billion).
This is the third trastuzumab biosimilar to be rejected by FDA. Both Pfizer’s proposed trastuzumab biosimilar (PF‑05280014) [2] and Celltrion’s candidate trastuzumab biosimilar (CT‑P6) [3] were rejected in April 2018. Both of which have been approved in Europe, as has Amgen’s trastuzumab biosimilar. Celltrion already resubmitted its application to FDA in May 2018 [4].
Amgen did not say why FDA had rejected its application, only stating that it had ‘received a complete response letter’. They did state, however, that they ‘will work closely with the FDA to bring this important medicine to patients in the US’. They added that they did not expect this to impact their US launch plan.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for Amgen’s trastuzumab biosimilar Kanjinti (ABP 980) in March 2018 [5]. The CHMP also recommended granting marketing authorization for Pfizer’s trastuzumab biosimilar Trazimera (PF‑05280014) in June 2018 [6].
Two other trastuzumab biosimilars have also been approved for use in the EU. Celltrion/Teva’s Herzuma (CT‑P6); received approval in February 2018 and Ontruzant (SB3), produced by Samsung Bioepis, received approval in November 2017 [7]. Mundipharma announced in May 2018 that it had launched Herzuma in the UK and Germany and anticipated further launches across European countries in the coming months.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Two trastuzumab biosimilars submitted to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/Two-trastuzumab-biosimilars-submitted-to-FDA
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects trastuzumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-trastuzumab-and-rituximab-biosimilars
3. 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 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Celltrion-Teva-s-rituximab-and-trastuzumab-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion resubmits biosimilar rituximab to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-resubmits-biosimilar-rituximab-to-FDA
5. GaBI Online - Generics and Biosimilars Initiative. EMA approval for trastuzumab biosimilar Kanjinti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-trastuzumab-biosimilar-Kanjinti
6. GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-adalimumab-and-trastuzumab-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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Source: Amgen, Mundipharma
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