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Two trastuzumab biosimilars submitted to FDA Posted 15/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.

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.

South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 31 July 2017 that the regulatory submission for their proposed trastuzumab biosimilar (CT‑P6) had been accepted by FDA.

The biosimilar application for CT‑P6 includes data comparing CT‑P6 and reference trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PDs) and pharmacokinetics (PKs). These trials were conducted in over 500 patients in 22 countries.

Biotech giant Amgen and its partner Allergan also announced on 31 July 2017 that the regulatory submission for their proposed trastuzumab biosimilar (ABP 980) had been accepted by FDA.

The biosimilar application for ABP 980 includes analytical, PK and clinical data, as well as pharmacology and toxicology data. The phase III comparative efficacy, safety and immunogenicity study was conducted in adult female patients with HER2+ early breast cancer.

Amgen and Allergan are collaborating on four oncology biosimilars. The companies also submitted their trastuzumab biosimilar for approval to the European Medicines Agency (EMA) in March 2017 [1]. The companies also submitted an application for their bevacizumab biosimilar to both FDA and EMA in November 2016 and December 2016, respectively [2]. Amgen has a total of nine biosimilars in its portfolio. It gained approval for its adalimumab biosimilar, Amjevita (adalimumab-atto), from FDA in September 2016 [3]. Allergan is also independently developing biosimilars.

Celltrion and Teva entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars (in the US and Canada in October 2016. The agreement involves Celltrion’s rituximab biosimilar (CT‑P10) and CT‑P6) [4].

The originator product, Roche’s Herceptin (trastuzumab), was approved by FDA in September 1998 and by EMA in August 2000 [5]. Herceptin had 2016 worldwide sales of CHF 6.8 billion (US$6.7 billion).

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References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen submits trastuzumab biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-trastuzumab-biosimilar-to-EMA
2. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab biosimilar application submitted to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-biosimilar-application-submitted-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 15]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Teva and Celltrion to partner on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/News/Teva-and-Celltrion-to-partner-on-biosimilars
5. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006

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Source: Amgen, Teva

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