China has a high burden of cancer. In 2018 there were 4.285 million newly diagnosed cancer patients and 2.865 million deaths from cancer in China [1]. According to research by Decision Resources Group, 2019 sales in China of major anticancer and immunotherapeutic biologicals that have either recently lost or are about to lose patent protection were nearly US$3 billion, of which less than 2% were from copy biologicals.

With more approvals on the way, the Chinese market for copy biologicals is expected to enjoy tremendous growth over the next 5–10 years and reach RMB 33 billion by 2025 (with a CAGR of 55% between 2019 and 2025), partly driven by adalimumab, bevacizumab, etanercept and trastuzumab, each with biosimilar sales above RMB 4 billion. By 2030, the market is expected to expand to RMB 49 billion and there are even some reports that suggest it may grow by 25 times in size by 2029. This may mean, however, that some markets for ‘first generation’ copy biologicals, such as bevacizumab, may become overcrowded leading to significant price cuts and forcing firms to develop their own competitive advantages, particularly low manufacturing costs and efficient distribution networks.

For China to enjoy the full benefits of copy biologicals, according to Hogan Lovells, two critical factors need to be addressed:

Government role: the government has a leading role to play at several key levels, starting with the inclusion of copy biologicals into the National Reimbursement Drug List (NDRL). In the 2017 NDRL, five oncology biologicals (four mAbs) were added including brand-name rituximab and bevacizumab. More biologicals are expected to be added to future NDRLs and subsequently copy biologicals. Further guidance and rules are needed to standardize manufacturing and distribution.

Education: market participants need to be informed and educated about the benefits of copy biologicals, through improved access to up-to-date knowledge and training in both technical and regulatory sciences. The copy biologicals that are currently developed in China need further improvement to match the brand-name drugs in terms of titre, bioreactor scale, capacity and, in some cases, quality. This may require significant resources over the next few years to inform and educate distributors, hospitals and doctors.

The market growth for copy biologicals in China is expected to increase the accessibility and affordability for biologicals in China. The entry of copy biologicals has already caused price erosion for brand-name drugs, e.g. Avastin and Herceptin (prices reduced by 23% and 24%, respectively) and Humira (prices reduced by 59%), as well as eroded the market share for the brand-name drugs.

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘copy biologicals’ approved in China might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related articles
Challenges facing copy biologicals in China

Investment increasing pipeline of copy biologicals in China

Improved regulation favouring copy biologicals in China

Patent expiries may drive development of copy biologicals in China

Reference
1. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 30]. Available from: www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Byvasda

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