Researchers Recommend Improvements for China’s Biosimilar Regulatory Policies

Researchers have made recommendations to improve the biosimilar regulatory system and refine biosimilar guidelines in China, in a new article published in Frontiers in Pharmacology.

Although China has the highest number of biosimilar drugs under research in the world (N = 391), laws and regulations for biosimilars in China, including a complete registration management system and supervision policies, are not “clearly formed.” As of the end of 2020, there have been 11 biosimilars approved for the Chinese market.

“There is an urgent need for a corresponding regulatory system for biosimilar drugs. While developing the laws and regulatory system, efforts should be made to avoid any deviations that happened in the evaluation of chemical generics and should focus on completing the task in hand in one attempt,” the authors wrote.

The following recommendations were suggested:

• Identifying reference drugs for biosimilar drugs
• Managing labels
• Nomenclature policies
• Defining interchangeable biological products
• Creating a catalog of marketed biologics

For identifying and obtaining reference drugs, the authors recommended that reference drugs be purchased from the Chinese market or the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) national markets approved by China.

Regarding managing labels, it’s difficult to ensure that the macromolecular structural characteristics of biosimilars are consistent with the reference biologics. Labels should state that the product is a biosimilar and include comparative safety and efficacy data “to provide sufficient information for clinicians to make prescription decisions," the authors wrote.

The authors exercised caution with indication extrapolation, saying that “extrapolated indications should be those approved for marketing in China in order to reduce the unknown risks posed by ethnic differences…declaration of all indications of the original biological products should be encouraged when marketed in China, in order to provide a reference basis for the extrapolation of the indications of their biosimilar drugs.”

When naming biosimilars, the authors recommended that biosimilars should have distinct names to attract the attention of clinicians, noting that although using a trade name for a biosimilar may be desirable by companies to establishing brand building, the name method is hard to implement in China because they may violate the current prescription management measures outlined by the Ministry of Health of the People’s Republic of China. The authors argued that a more mature policy environment for biosimilars may need to be established.

Additionally, the authors stressed that incentive policies, such as reimbursement opportunities, are essential to ensure market fairness and access. Prices should be set reasonably and be based on the research and development investment.

"Whether in China or European or American countries, greater price reduction may be the problem that biosimilar drugs need to address directly,” the authors wrote.

Because the Chinese biosimilar market is in its early stages, the authors expressed that physicians should be the sole decision makers on which product patients should be prescribed, recommending that China should hold off on granting interchangeability to biosimilars.

Finally, the authors said that China should establish a biosimilar catalog to encourage biosimilar development and provide information for the general public and health care professionals. The catalog should include approval information, designated reference drugs, and data protection information of the originator.

Reference

Yang J, Zhao X, Li J, et al. Creating China’s biosimilar drugs regulatory system: a calculated approach. Front Pharmacol. Published online February 2, 2023. doi:10.3389/fphar.2022.815074