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EMA accepts first application for Chinese-made biosimilar HLX02 Posted 09/08/2019

China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).

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 EMA submission is based on a data package that includes results from a phase III study, which carried out a head-to-head similarity evaluation in efficacy, safety and immunogenicity profiles between HLX02 and reference trastuzumab sourced from the European Union (EU) in 649 previously untreated patients with HER2+ metastatic breast cancer in mainland China, the Philippines, Poland and Ukraine [1]. In addition, data from a phase I study, that the company says, ‘successfully demonstrated the equivalence in pharmacokinetics and safety profiles between HLX02 and reference trastuzumab sourced from both EU and China’, were also provided.

Henlius also reported that the new drug application (NDA) for HLX02 had been accepted for review by the National Medical Products Administration (NMPA) in China.

Henlius has out-licensed the European rights for HLX02 to its business partner Accord Healthcare (Accord). Henlius and Accord signed licencing and supply agreements back in June 2018, giving Accord the exclusive rights to commercialize HLX02 in 53 countries including France, Germany, Italy and the UK in Europe; 17 countries in Middle East and North Africa (MENA) and certain countries in the Commonwealth of Independent States (CIS).

Henlius says that ‘the acceptance for review by the EMA demonstrates that the "China-developed" biosimilar has entered the global stage with the hope to benefit patients globally’.

The company’s rituximab copy biological (HLX01) has been successfully launched in China. Also, in addition to HLX02, Henlius has an adalimumab copy biological (HLX03) that has also been accepted for NMPA review. The company also has a robust R & D pipeline with investigational new drug and clinical trial application (IND/CTA) filing for 13 products and two combination therapies in 23 indications.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Positive results for Chinese rituximab and trastuzumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-Chinese-rituximab-and-trastuzumab-copy-biologicals 

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Source: EMA, Henlius

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