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EMA approves adalimumab and trastuzumab biosimilars Posted 08/06/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 June 2018 that it had recommended granting marketing authorization for the adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz, and also for the trastuzumab biosimilar Trazimera.

Halimatoz, Hefiya and Hyrimoz are produced by Sandoz, the generics division of Novartis. The company had its candidate adalimumab biosimilar (GP2017) accepted for regulatory review by EMA in June 2017 [1] and by the US Food and Drug Administration (FDA) in January 2018 [2].

The CHMP has recommended that Halimatoz, Hefiya and Hyrimoz be approved for the treatment of certain inflammatory and autoimmune disorders. Sandoz said that this includes all indications of the reference medicine (AbbVie’s Humira), which includes rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis.

The positive CHMP opinion has been based on a comprehensive data package, which includes analytical, preclinical and clinical data. This data, according to Sandoz, demonstrates that the proposed biosimilar adalimumab matches the reference biological in terms of safety, efficacy and quality. A randomized, double-blind, three-arm parallel study was conducted to determine the pharmacokinetics (PKs), immunogenicity and safety of biosimilar adalimumab. The study met its primary objective in demonstrating PK bioequivalence. Additionally, clinical studies submitted for review include the phase III confirmatory safety and efficacy study in patients with moderate to severe chronic plaque-type psoriasis (ADACCESS).

Four adalimumab biosimilars have already been approved for use in the European Union (EU). Amgen’s Amgevita and Solymbic received European Commission (EC) approval in March 2017; Imraldi, produced by Samsung Bioepis, received approval in August 2017; and Boehringer Ingelheim’s Cyltezo (BI 695501) received approval in September 2017 [3].

Trazimera is produced by pharma giant Pfizer. The candidate trastuzumab biosimilar (PF‑05280014) was submitted to EMA and FDA for approval in September 2017 [4]. However, the US application was rejected by FDA in April 2018 [5].

The CHMP has recommended that Trazimera be approved for the treatment of breast and gastric cancer.

There are already three trastuzumab biosimilars approved for use in the EU. Amgen’s Kanjinti (ABP 980) received EC approval in March 2018; Celltrion/Teva’s Herzuma (CT‑P6); received approval in February 2018 and Ontruzant (SB3), produced by Samsung Bioepis, received approval in November 2017 [3].

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Biosimilars of trastuzumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-and-infliximab-biosimilars-from-Sandoz-accepted-for-review-by-EMA
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts applications for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-applications-for-adalimumab-and-trastuzumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. 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 Jun 8]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-Pfizer-s-trastuzumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA rejects trastuzumab and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-trastuzumab-and-rituximab-biosimilars

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Source: EMA, Sandoz

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