Recently, Cell’s Trends in Biotechnology (impact factor 21.942) published a short article about the regulatory differences between two major markets, Europe and China, using the first Chinese biosimilar approved in both China and the EU, HANQUYOU (trastuzumab for injection, HLX02, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®) as an example.

The article illustrated that biosimilars can improve accessibility for patients and save medical expenses effectively. Europe is one of the earliest regions to approve the marketing of biosimilars and has since become one of the established markets for biosimilars in the world. In 2005, the European Medicines Agency (EMA) issued the first regulatory guidelines for biosimilars. China National Medical Products Administration (NMPA) released the Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative) in 2015, and guidelines such as similarity evaluation and indication extrapolation were subsequently introduced. 

HANQUYOU is the first China-developed monoclonal antibody (mAb) approved both in China and Europe. This article also mentioned that a series of reforms of China's biosimilar regulations have effectively promoted market development. As illustrated by HANQUYOU, there is a plethora of similarities in the scientific rigor and regulatory processes for biosimilar approval by both the NMPA and EMA, but there are certain differences in data requirements and review criteria. The convergence of effective communication and addressing specific requirements in review criteria is key to expediting parallel marketing authorisation applications (MAA) approval in different regions. It takes 12.5 months for HANQUYOU from under priority review to NMPA approval, which is shorter than the average evaluation time for biologics (14 months). It took HANQUYOU about 13 months from EMA MAA validation to approval.

HANQUYOU was approved for commercialisation by the European Commission (EC) and NMPA in July 2020 and August 2020, respectively, which is now indicated for the treatment of HER2 positive breast cancer and gastric cancer. Up to now, HANQUYOU has benefitted more than 100,000 Chinese patients. The approval is based on head-to-head clinical studies of HANQUYOU and the reference trastuzumab, including comparative analytical studies, nonclinical studies, a phase 1 Pharmacokinetics similarity study and a global multicentric phase 3 safety, efficacy and immunogenicity study in relevant patient populations comparing HANQUYOU to the reference trastuzumab. The clinical results proved that HANQUYOU and reference trastuzumab are highly similar in terms of quality, safety, and efficacy. To date, HANQUYOU was approved in more than 30 countries, including China, the United Kingdom, Germany, France, Switzerland, Australia, Argentina, and Saudi Arabia. The Biologics License Application (BLA) of HANQUYOU has also been accepted by the U.S. Food and Drug Administration (FDA).

Henlius has accumulated extensive experience in the regulatory and review procedures related to investigational new drugs (IND) and marketing authorisation applications in various countries and regions including China, the US, Europe, and Australia. Over 70 clinical approvals and 18 marketing authorisations have been obtained worldwide, covering 50 countries and regions. With a clear and specific R&D strategy, high-efficient clinical operation capability and flexible regulatory strategy, Henlius accelerates the clinical trial process and products registration at full speed. To date, 5 products have been launched in China, 1 approved for marketing in overseas markets, and 1 was granted orphan drug designations by the U.S. FDA and the EC. Henlius will take full advantage of the company’s expertise in regulatory affairs to continue promoting products so that more patients worldwide can be benefitted.

AboutTrends in Biotechnology

Trends in Biotechnology (TIBTECH) publishes reviews and perspectives on the applied biological sciences: useful science applied to, derived from, or inspired by living systems. The major themes that TIBTECH is interested in including Bioprocessing, Omics, Materials and devices, Therapeutics and Agroenvironment. TIBTECH particularly seek articles that are relevant to more than one of these themes. Additionally, TIBTECH welcome articles on law and intellectual property, policy and regulation, bioethics, scientific communication, and the economics of biotechnology.