China's Biosimilar Market: Trastuzumab Uptake and Future Trends

Despite rapid growth of the biosimilar industry in China, the market uptake of trastuzumab biosimilars in China is lower compared with major European countries, according to a study published in Global Health Research and Policy.1

High costs of biologics put heavy burdens on worldwide health care systems with the global expenditure reaching $452 billion in 2022. For patients with inflammatory bowel disease, average direct health care expenses are $9000 to $12,000 per person per year in various high-income areas.2 Medication prices in the US typically surpass international costs due to lack of nationwide price regulation, the fragmentation of the health care system, prolonged market exclusivity periods, and confidential rebates negotiated between private insurers and pharmaceutical manufacturers.

It is vital to develop a balance between biomedical innovation and the sustainability of health care systems.1 Biosimilars have the potential to increase payer preferences and market share which led to major price reductions and evidence of a competitive market between 2017 to 2022.3 However, barriers persist, especially surrounding doubt about the safety and efficacy of biosimilars that lead to negative attitudes and unwillingness.1

In recent years, the Chinese biosimilar industry has grown but there is limited research on the uptake of biosimilars at the national level. With the approval of the trastuzumab biosimilar, the Chinese market now has access to both individual hospitals and provincial-level administrative divisions (PLADs) to analyze a large sample size.

The study authors looked to provide evidence for promoting the clinical use of biosimilars and improve the accessibility for biological therapy, which would also help other resource-limited countries to address the issue of access to expensive bio-therapy. They conducted the study because "there is a lack of research on the uptake of biosimilars at the national level."

Researchers conducted an analysis based on monthly time series consumption data of trastuzumab in Chinese hospitals on a national scale and applied the interrupted time series regression. The latent class trajectory model (LCTM) was adopted to demonstrate provincial differences and acknowledge potential factors that may alter biosimilar market penetration across PLADs.

On a national level, trastuzumab consumption volume fluctuated upward during the observation period. After the first biosimilar was introduced in July 2021, consumption of originator trastuzumab decreased by 0.5% per month (P = .008) and the growth rate of the overall trastuzumab consumption decreased by 1.1% per month (P = .014). The national market penetration of biosimilars expressed a moderate increasing trend that reached 27% in February 2023.

Between March 2018 to January 2020, the national consumption of the trastuzumab originator grew at a rate of 2.5% per month (P < .001). During this period, the overall trastuzumab consumption volume showed an increasing trend, with an average monthly growth rate of 2.5% (P < .001).

Following the price reduction of trastuzumab originator in January 2020, consumption dropped by 13.1% (P = .029), accompanied by a 1.9% decrease in growth (P = .001). In July 2021, the introduction of the first biosimilar brought a decreased growth rate of the originator consumption by 1.1% (P = .019) with steady decreases by 0.5% per month (P = .008).

When the price of the originator reduced (P = .016), the overall consumption of trastuzumab instantly decreased by 14.7%, while the growth rate declined by 1.6% (P = .005) and maintained a growth rate of 0.9% per month (P = .031).

The LCTM fit the best when the amount of trajectory classes for biosimilar market penetration rate was 2, leading to 30 PLADs divided into a group demonstrating a faster increase in biosimilar penetration and the other with a slower increase.

There were more PLADs in the fast-increasing group with higher proportions of the population covered by the national basic health insurance but had a lower proportion of the urban population to the total population. There was also a lower proportion of the population covered by the urban employee health insurance program, a lower gross domestic product per capita, a lower total health expenditure per capita, and a lower out-of-pocket expenditure. Overall, national sales volume of trastuzumab emtansine showed average growth, reaching $1 million in September 2021 and fluctuated around $0.9 million.

Study results suggest biosimilars can invoke a transition in treatment from the originator to the biosimilars. The biosimilar market penetration in China is close to several developed countries across Asia and North America. However, uptake remains low in China compared with European countries where market shares show increases over time leading to reductions in expenditures. For instance, the Netherlands experienced significant price reductions and increased market share following the introduction of the trastuzumab biosimilar.4

Limitations include a focus on hospital consumption, ultimately neglecting community pharmacies. Additionally, market fluctuations and the brief availability of biosimilars introduced barriers. The study was restricted to a single biological agent and lacked individual case study data for deeper analysis. Future research should consider a broader market perspective and quantitative analysis of competitive agents' influence.

By enhancing comprehension of biosimilars between physicians and patients while implementing provider payment reforms, competition could stimulate and foster market penetration of biosimilars.

“These measures are also meaningful for other resource-limited countries to promote biosimilar uptake and address the issue of access to expensive bio-therapy,” concluded study authors.

References

1. Wu Q, Wang Z, Fu Y, Luo R, Sun J. Uptake of biosimilars in China: a retrospective analysis of the case of trastuzumab from 2018 to 2023. Glob Health Res Policy. 2024;9(1):42. doi:10.1186/s41256-024-00372-z

2. Ferreri D. Making the cost of IBD care sustainable. The Center for Biosimilars®. November 2, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/making-the-cost-of-ibd-care-sustainable

3. Jeremias S. Commercial payer coverage of biosimilars: market share, pricing, and policy shifts. The Center for Biosimilars. December 4, 2024. Accessed December 16, 2024. https://www.centerforbiosimilars.com/view/commercial-payer-coverage-of-biosimilars-market-share-pricing-and-policy-shifts

4. Santoro C. Trastuzumab’s evergreening impact on biosimilars, health care costs. The Center for Biosimilars. December 13, 2024. Accessed December 17, 2024. https://www.centerforbiosimilars.com/view/trastuzumab-s-evergreening-impact-on-biosimilars-health-care-costs