Henlius Biotech’s announced its much anticipated EMA approval. We have covered in extensive detail how this is a first foray for a Chinese biosimilar company in a regulated market. Its candidate, HLX-02, now sold under the brand name Zercepac®, is a trastuzumab biosimilar referencing Roche’s Herceptin and will be the sixth trastuzumab biosimilar in the EU. It is intended for use in cancers overexpressing HER-2, which occurs in almost 25% of breast cancers and 20% gastric cancers. The approval comes based on data following a global multi-center phase iii study which compared the efficacy and evaluated the safety and immunogenicity of the biosimilar against Herceptin in HER-2 positive patients with recurrent or previously untreated metastatic breast cancer.
Henlius in partnerships with Accord Healthcare (a subsidiary of Intas Pharmaceuticals), Mabxience, Cipla and Jacobson Medical will market the biosimilar in over 80 countries. Accord is a rapidly growing biosimilars and generics player in the European Union and has acquired exclusive commercial rights to commercialize Zercepac® in Europe and few other geographies. In EU, it currently markets two – filgrastim (Accofil) and pegfilgrastim (Pelgraz) biosimilars. The latest trastuzumab biosimilar approval marks its first biosimilar product in the monoclonal antibody category. It is also interesting to note that Accord currently markets a trastuzumab biosimilar in its home-country India but none in any regulated market, until now. The partnership is therefore strategically forged considering the increasingly competitive space of biosimilars and timing being the essence for value realization, more so in the case of trastuzumab with immense competition in both EU and US. Through the strategic marketing partnership, Henlius will leverage Accord’s expertise in navigating through the EU regulatory pathway and now depends on its expertise in serving the oncology market in EU, while Accord gets to expand its biosimilars pipeline and oncology portfolio. With the partnership, Accord continues to reassert itself as a global generic and biosimilars provider.