A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that manufactured by a different company. Biosimilar are officially approved versions of original "innovator" products and can manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all biopharmaceuticals, including biosimilar, must maintain consistent quality and clinical performance throughout their lifecycle.
The China Biosimilar market size is projected to reach US$ 5673.39 million by 2027, from US$ 631.56 million in 2020, at a CAGR of 27.44% during 2021-2027. The market driver list: the need for innovative therapies in China – particularly in areas such as oncology – has never been greater; a large number of blockbuster biologics are coming off patent between 2019 and 2027; the Chinese government is looking for alternatives to curb rising expenses from branded/originator drugs and is establishing a robust regulatory framework. Chinese manufacturers are closing the gap with global peers in terms of R&D expertise and investments.
Although the market for biosimilar has broad development prospects, China biosimilar still faces many challenges:
At the national level, the system of laws, regulations and technical standards is not yet complete, lack of supporting incentive policies, including priority reviews, payment systems, medical insurance policies, etc., and lack of a complete pharmacovigilance system. Therefore, further improving the legal and regulatory system and technical standard system, formulating supporting policies for the entire life cycle, and improving the drug safety monitoring system have become the next key tasks.
At the technical level, there are many uncertain factors in this field itself, and there are problems in many aspects such as similarity evaluation standards, indications extrapolation, and the connection of evaluations between gradual and progressive studies. Regulatory agencies, academic institutions, and companies need to communicate with each other and issue relevant guidelines to strengthen post-listing risk control and safety monitoring.
At present, the country is in a period of key strategic opportunities from imitation to the combination of imitation and innovation. With the support of "major new drug creation" and other special science and technology projects, the overall capability of China's biosimilar drugs in each key link of research and development has been significantly improved, and the industrialization chain Continuous improvement.
A critical factor in Europe’s early adoption of biosimilars was its more favorable regulatory environment. For example, Northern Europe has world leading biosimilar adoption rates, helped by its local tendering systems and national policies encouraging physician-led switching. In addition, the EMA was the first agency to establish regulatory guidelines for “similar biological medicinal products” (i.e. biosimilars) as early as 2005.
The US responded in 2009 with the Biologics Price Competition and Innovation Act (BPCIA), which provided a regulatory approval pathway for biosimilars – the 351(k) route of the Public Health Service (PHS) Act. However, the pace of adoption of biosimilars has been underwhelming in the US, with the first biosimilar only approved in 2015, or 24 years after the innovator product hit the market.
Facing a rapid increase in healthcare expenses, China is looking for solutions and taking a proactive approach to solving this problem including developing alternatives to expensive brand drugs (including the recent GPO/4+7 tender trial). Considering the significant improvements achieved in the Chinese pharmaceutical regulatory environment over the past few years, we believe that generics and biosimilars offer attractive solutions.
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