PMU43 Biosimilar in China: Will Indication-Based Approach Help Improve Patient Access?

Abstract

Since the introduction of biosimilars in 2004, China has become a market with enormous potential given the demand for more affordable therapeutic alternatives. We explored the approaches taken by biosimilar manufacturers, especially around their choices of initial indications at launch. We used rituximab as an example for this analysis. We conducted a non-systematic review of public data sources to identify formal guidance for biosimilar development. For rituximab, we reviewed ongoing and proposed clinical trials for rituximab and its biosimilars in China. Biosimilars offer a more affordable alternative than biologics in several indications and may improve patient access, as drug cost can be a challenge for Chinese patients on public health insurance programs. Rituximab is currently approved for three indications - Non-Hodgkin’s Lymphoma (NHL), Diffuse Large B-cell NHL (DLBCL), and Chronic Lymphocytic Leukemia (CLL). The first rituximab biosimilar, HLX01 was approved in February 2019 by the Chinese National Medicinal Products Administration (NMPA) for two of those indications - NHL and DLBCL. Domestic biotechnology company Innovent in collaboration with Eli Lilly followed shortly with an application for IBI301 in CD20-Positive Lymphoma which was accepted for review in June 2019. As of July 2nd, 2020, there are two active biosimilar clinical trials for HLX01; one open-label Phase II (NCT04361279) in patients with indolent B-cell Lymphoma (iBCL), and a Phase III (NCT03522415) in patients with Rheumatoid Arthritis (RA). Rituximab does not currently have a clinical trial in development for RA nor iBCL in China. Biosimilar development is typically focused on originator on-label indications. However, with an active trial in iBCL, HLX01 may be seeking to demonstrate clinical benefit in targeted patient subgroups that are more difficult-to-treat in the on-label indications as compared to rituximab. This would potentially improve physician perceptions of biosimilars and their willingness to prescribe and use in clinical practice.