Adalimumab and trastuzumab biosimilars gain EC approval

Biosimilars/News | Posted 21/09/2018 post-comment0 Post your comment

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).


Pharma giant Pfizer announced on 31 July 2018 that it had received EC approval for its biosimilar trastuzumab product Trazimera (PF‑05280014).

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 cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

The EC approval of Trazimera is based on a comprehensive submission package which, according to Pfizer, ‘demonstrated a high degree of similarity for Trazimera and the originator product’. The data included results from the REFLECTIONS B327-02 clinical comparative study [1], which ‘showed clinical equivalence and found no clinically meaningful differences’ between Trazimera and the originator product, Roche’s Herceptin (trastuzumab), in patients with first-line HER2 overexpressing metastatic breast cancer.

The EC has also approved the adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz (GP2017), produced by Sandoz, the generics division of Novartis.

The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biological, AbbVie’s Humira (adalimumab), in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A phase III confirmatory safety and efficacy study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic. No meaningful clinical differences were observed.

These approvals by the EC follow the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendations on 1 June 2018 [2].

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1.  GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for Pfizer’s trastuzumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from:
2.  GaBI Online - Generics and Biosimilars Initiative. EMA approves adalimumab and trastuzumab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 21]. Available from:

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Source: EMA, Pfizer, Sandoz

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