China’s streamlined system for biologics approvals has enabled Shanghai Henlius Biotech to bring biosimilars to market faster and potentially at a lower cost, Ping Cao, vice president of Business Development, explains.
The Center for Biosimilars® spoke recently with Ping Cao, vice president of Business Development for Shanghai Henlius Biotech about the company’s business activities and conditions for biosimilar developers in the Chinese market. Established in 2010, Henlius is notable for having brought the first biosimilar to the Chinese market, a rituximab product. Henlius has a robust pipeline of products and ambitions to partner with companies abroad for global sales development.
In the interview, Cao talks about recent changes in Chinese guidance for biosimilar development and how these have quickened the pace of approvals and improved conditions for companies entering these markets. For example, previously it may have taken 3 years from the time of an investigational new drug (IND) application to gain regulatory approval to commence a clinical trial. That timeline has been shortened to 60 days under the new regulatory standard in China, which has established timing guarantees that allow companies to proceed if they do not receive a response to IND applications within 2 months.
In this sense, the Chinese government has been an active partner with the biologics industry and has extended opportunities for talks with the business sector on how to further improve the regulatory system. This bodes well for the future of biosimilars development and marketing, Cao explains.
Cao also provides a comparison of the regulatory environments in the United States and China and discusses the competitive dynamics of producing biosimilars and gaining market share as the number of competitors and competing products continue to increase. For Henlius, the costs of producing a biosimilar can range up to $100 million, and to meet regulatory standards in the United States and European Union, the costs could go higher than that, Cao explains. Meanwhile, producers need to keep their biosimilar prices competitive with what others are charging. Therefore, these 2 dynamics—cost of production and pricing—may move on opposing trendlines.
Cao also talks about the promising market in China for the company’s adalimumab biosimilar (referencing Humira), which was approved by China’s National Medical Products Administration in late 2020 for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis. Within China, Henlius has an extensive network of hospital partners and a large sales team, with which the company believes it can reach a population exceeding 6 million patients in China.
For more reading about Henlius’ biosimilars portfolio, pipeline, and global development ambitions, click here.