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Navigating post-market access and adoption of biosimilars across APAC

Many factors influence post-market success of a therapeutic. Public health needs, drug reimbursement policies and safety follow-up requirements all contribute to how a drug performs after reaches the market. Biosimilars are a unique case, since they closely emulate existing biologics, but cannot be exact replicas of their reference drugs.

Sponsors aiming to enter the international biosimilars market must be equipped to navigate regional variations in regulatory landscapes, healthcare systems and market dynamics. As the Asia-Pacific (APAC) region continues to emerge as a key player in the biosimilar sector, it presents significant opportunity for market expansion. This analysis explores critical post-market positioning considerations for biosimilars in several prominent APAC countries, including China, Japan, India, Singapore and South Korea. 

Market competition, innovation and incentives shaping biosimilar uptake in China

Biosimilars are, in general, not treated as a unique type of therapeutic in China. As a result, their post-market follow-up requirements are the same as for any other biologics that have received marketing authorisation in the country. These measures include establishing a detailed pharmacovigilance plan, periodic safety update reports and post-market safety studies to identify any risks to patient safety or public health. 

Given the rapid growth of China’s biosimilars market, sponsors should anticipate a highly competitive landscape. The introduction of newly approved biologics targeting the same indication can diminish demand for biosimilars of older therapies. Trastuzumab illustrates this trend: once a cornerstone treatment for HER2-positive breast cancer, its biosimilar uptake has declined with the advent of newer, more advanced therapies.1 This shift is further driven by China’s rising prominence in global biotech innovation.

The implementation of Diagnosis-Related Groups (DRGs) in China represents a fundamental shift in healthcare reimbursement, aiming to improve cost-efficiency across the system. Chinese physicians and hospitals are incentivised to prescribe biosimilars. Under this model, patients are classified into diagnostic categories, based on standardised criteria such as disease severity and treatment complexity. Hospitals are reimbursed a fixed amount per case, independent of the specific itemised services and medications.

This prospective payment structure creates a strong economic incentive for healthcare providers to reduce treatment costs. Since biosimilars offer comparable clinical efficacy to the reference product but at a lower price point, they are a logical choice for patient treatment within this framework. Furthermore, hospitals are permitted to retain any surplus funds when actual treatment costs fall below the DRG reimbursement rate, reinforcing the motivation to select cost-effective therapies.

Despite these structural incentives, biosimilar uptake in China has, in some instances, remained lower than in many European markets. This disparity may be attributed to several factors, such as physician familiarity, patient trust or acceptance, or policy inconsistencies across provincial divisions. Addressing these barriers will be essential to unlocking the full cost-saving potential of biosimilars within China’s evolving healthcare landscape.

Access to biosimilars in India: the role of insurance and regulation

Health insurance coverage in India is highly decentralised and fragmented. Citizens rely on a mix of private and health public insurance policies, each offering varying levels of coverage. As a result, access to biosimilars can vary widely depending on the specific insurance plan, with some policies providing more comprehensive reimbursement than others. Moreover, by some estimates, approximately 30% of the population remains uninsured, placing a substantial burden on individuals who must pay out of pocket for their medical care.2 Hence, more affordable treatment options such as biosimilars are critical to expanding treatment access and reducing out-of-pocket costs. Because of India’s faster uptake of biosimilars, patients are more likely to seek them out as treatment options.

In addition to insurance coverage, regulatory oversight plays a major role in shaping patient access to biosimilars. India, like many other countries, requires a risk management plan for all biosimilar products. This plan must include a well-defined, post-marketing pharmacovigilence strategy, including a system for adverse event reporting. Sponsors must clearly outline how potential safety concerns for a drug will be identified, assessed and mitigated. Furthermore, India's biosimilar guidelines include the potential requirement of a post-marketing study to be conducted within two years of market authorisation. These studies are usually single-armed and benchmarked against the historical data of the reference biologic, allowing for a structured assessment of real-world safety and efficacy of the approved biosimilar.

Together, these insurance and regulatory frameworks form the backbone of India’s approach to biosimilar access – an increasingly important aspect of improving both healthcare affordability and availability to patients and providers.

Oncology incentives and post-market oversight shaping biosimilar adoption in Japan

Japan’s rapidly aging population has created favourable conditions for the adoption of biosimilars, particularly those targeting age-related diseases. Recognising the growing demand of its elderly citizens, the Japanese government has strategically prioritised biosimilars for oncology indications through their policy and reimbursement measures. In 2022, the government introduced a biosimilar adoption incentive as part of its national fee schedule. This program offers modest financial incentives to eligible hospitals to prescribe select oncology biosimilars. The impact of this initiative has been significant. Since its implementation, uptake of oncology biosimilars has accelerated, underscoring the effectiveness of financial incentives in shaping prescribing behaviour, encouraging broader adoption across the healthcare system and creating promising future biosimilar growth. 

In Japan, it is a requirement that a risk management plan be submitted as part of a biosimilar approval application. Such a plan must consider the following:

  • Clinical trials limitations and items that could not be fully evaluated during clinical trials
  • Post-market drug information obtained in other countries
  • Quality attributes — such as protein structure, biological activity, purity and stability — which are critical to ensuring the biosimilar's safety, efficacy and similarity to the reference product 

Japanese guidance also recommends the construction and use of disease registries to promote reliability in situations where the target population is small, or multiple companies have created biosimilars of the same reference drug.

Biosimilar growth in Singapore: Policy, public health and vigilance

Policies in Singapore strongly encourage biosimilar adoption. As biosimilars enter the market, they are evaluated for funding consideration by the Drug Advisory Committee — an expert panel under the Ministry of Health that assesses drugs for inclusion on national subsidy lists. If the reference product is no longer considered cost-effective, it may be recommended for removal from subsidy lists and replaced by biosimilars, depending on evidence and pricing proposals. Such subsidy listings lead to a rapid uptake of biosimilars. In fact, three biosimilars were found to account for 95% of their respective market shares within a single year of subsidy implementation.3 This leads to a highly favourable market for biosimilars. However, it also encourages price reductions to ensure that biosimilars maintain preferential value, leaving sponsors to strike a delicate balance.

These policy incentives align with Singapore’s evolving public health landscape, in which chronic diseases are becoming increasingly prevalent. Although diabetes and hyperlipidaemia rates have declined since 2017, obesity and hypertension rates have risen. Therefore, biosimilars targeting these chronic conditions are expected to be of particular interest to the Singapore market.

Given the increasing burden of chronic conditions, regulatory oversight remains crucial to ensure biosimilar safety and efficacy. In 2024, Singapore’s Health Sciences Authority updated its guidance on post-marketing vigilance requirements. Most notably, it removed the requirement for the submission of a risk management plan. This change reflects a shift toward integrating risk management into routine pharmacovigilance practices, rather than requiring a separate plan for biosimilars. Nevertheless, all products registered in Singapore remain subject to routine pharmacovigilance and risk minimisation requirements.

Market dynamics and public health drivers shaping biosimilar uptake in South Korea

The development and uptake of biosimilars is encouraged by the South Korean government, as demonstrated by the eligibility of biosimilars for reimbursement through its single-payer health system. All drugs must undergo a pharmacoeconomic evaluation prior to being listed on Korea’s formulary, requiring a demonstration of comparative effectiveness and cost effectiveness. This evaluation informs price negotiations with Korea’s health system. 

While some biosimilars have shown a gradual proportional increase in Korean market share in the years following approval, this is somewhat mitigated by originator drugs reducing their prices in anticipation of biosimilars entering the market.4 Because this creates only minimal cost savings for physicians and patients who would otherwise select the biosimilar, there is less motivation to do so.

These market dynamics exist alongside important public health trends, including a rise in chronic diseases such as diabetes and age-related illnesses associated with South Korea’s high life expectancy. Biosimilar developers focusing on these areas may find significant opportunities in this market.

Given these public health challenges, regulatory oversight remains a key component of South Korea’s approach to biosimilars. As is the case for all medicinal products, South Korea requires post-market safety monitoring for biosimilars. Its evaluation guidelines place a particular emphasis on surveillance for anti-drug antibody serious adverse reactions and state that additional immunogenicity data may be required as a part of post-market surveillance.

Paving the way for biosimilar success

The elements contributing to post-market access and success for biosimilars are many and varied. As such, it is essential for sponsors to carefully evaluate the specific trends, policies and regulatory framework shaping each national market prior to pursuing authorisation. Encouragingly, several countries in the APAC region are beginning to distinguish themselves as leaders in biosimilar development and adoption. Through supportive policies, reimbursement incentives and evolving regulatory approaches, these emerging APAC markets are paving the way for broader biosimilar use — pointing to a promising future for biosimilars in the region.

 

If you would like to know more about how ICON’s Centre for Biosimilar Drug Development can support your project, please Contact Us today.

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References

1 Wu, Qiyou, et al. “Uptake of Biosimilars in China: A Retrospective Analysis of the Case of Trastuzumab from 2018 to 2023.” Global Health Research and Policy, vol. 9, no. 1, Oct. 2024, p. 42, https://doi.org/10.1186/s41256-024-00372-z.

2 Pradhan, Dipen. “Top Health Insurance Statistics Of 2025.” Forbes Advisor INDIA, 23 Sept. 2024, https://www.forbes.com/advisor/in/health-insurance/health-insurance-statistics/.

3 Tan, She Hui, et al. “Impact of Value-Driven Healthcare Strategies for Biosimilar Adoption: The Singapore Story.” PharmacoEconomics Open, vol. 8, no. 5, July 2024, pp. 679–88, https://doi.org/10.1007/s41669-024-00491-w.

4 Cho, Soo-Kyung, et al. “Uptake of Biosimilars and Its Economic Implication for the Treatment of Patients with Rheumatoid Arthritis in Korea.” Journal of Korean Medical Science, vol. 36, no. 20, May 2021, https://doi.org/10.3346/jkms.2021.36.e143.

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