China’s young biosimilars sector saw a major milestone in December which underlines the sector’s rapid growth and significant promise: the first marketing approval of a domestically-developed biosimilar of Avastin. Ankada, developed by Qilu Pharmaceutical, has received marketing approval from the China National Medical Products Administration (NMPA) for the treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. China approved its first biosimilar – Shanghai Henlius Biotech’s (China) HLX01 (also marketed as Hanlikang) – a biosimilar of Swiss firm Roche’s Rituxan (rituximab) only in February 2019.
The approval of Ankada underscores the Chinese government’s eagerness to curb the country’s soaring healthcare spending, and indicates that more, similar marketing approvals are soon to come. IHS Markit forecasts that China’s total healthcare spending will grow by 10.0% in 2019, and by 10.4% in 2020 to reach CNY5,359.4 billion (USD764.5 billion) in 2020. According to IHS Markit’s Biosimilars Market Database, Shanghai Henlius Biotech’s clinical pipeline includes two other biosimilar candidates currently in Phase III clinical development, that reference Roche treatments Herceptin and Avastin, a biosimilar of the Swiss company’s Kadcyla for the treatment of HER2-positive breast cancer, as well as a biosimilar referencing AbbVie’s Humira. The NMPA has also granted marketing approval to Bio-Thera Solutions’ Qletli, which references Humira, for the treatment of all eligible indications of Humira in China.
The NMPA has also approved several clinical trial applications for biosimilars, including from South Korean company Samsung Bioepis for its trastuzumab biosimilar Ontruzant, as well as for Chinese company Clover Biopharmaceuticals’ SCB-808, a biosimilar referencing Amgen and Pfizer’s Enbrel, for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases.
However, China’s push to grow its biosimilar market is expected to significantly increase competition for manufacturers of originators – including Roche, which faces direct competition for trastuzumab, bevacizumab, and rituximab in China from locally-made biosimilars. Hanlikang, for example, is reportedly priced approximately 30% lower than Roche’s Rituxan, which is listed on China’s National Reimbursement Drug List (NRDL).
In addition, an increasing number of pharmaceutical multinationals have signed collaboration agreements targeting China’s biosimilar space. These include Samsung Bioepis and 3SBio’s collaboration agreement in January 2019 to develop, seek regulatory approval for and commercialise the South Korean drugmaker’s biosimilar candidates; Ascentage Pharma and Henlius’ collaboration on the development of the combination of APG-2575 and Hanlikang for the treatment of chronic lymphocytic leukaemia; and Celltrion’s joint venture with Nan Fung Group to develop and commercialise biosimilars in mainland China, including the South Korean company’s Remsima (biosimilar referencing infliximab), Truxima (rituximab-abbs), and Herzuma (trastuzumab-pkrb).
It is also noteworthy that China’s national guidelines on its regulations for biosimilars, which were first released in 2015, has brought the country more into line with standards in the United States and Europe. Among the guidelines is a requirement that reference products must be approved in China prior to the start of clinical trials, potentially enabling the NMPA to improve its monitoring of biosimilar standards. Overall, the similarity of the guidelines to their European counterparts is likely to foster foreign investment in the world’s second-largest pharmaceutical market, driven in part by a wave of patent expiries worldwide.
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