China’s Biosimilar VBP: Emerging Rules, Pricing Dynamics, and What Early Signals Suggest
China’s National Volume-Based Procurement (NVBP) has become one of the country’s most influential policy levers for controlling medicine costs and advancing universal healthcare coverage. Its core focus is clear: prioritize mature products within the basic medical insurance catalog that have high utilization and large procurement value, ensuring affordability for the public payer while promoting rational, standardized use across the health system.
A distinctive feature of China’s system—compared with similar policies globally—is the Generic Consistency Evaluation (GCE). Originally introduced for generics approved before 2016 that had not undergone rigorous equivalence testing, GCE serves as a quality gatekeeper for NVBP participation and laid the groundwork for VBP implementation.
Another defining element of NVBP is its guaranteed procurement volume for winning bidders, especially the primary winner. This mechanism gives the public payer extraordinary bargaining power, while simultaneously offering suppliers the certainty needed to achieve economies of scale. For some companies, NVBP participation has accelerated the transition from modest market presence to major industry player.
A similar evolution is now unfolding in China’s biosimilar market. Since the approval of China’s first domestic biosimilar in 2019, more than 50 biosimilars have received regulatory approval by 2023. On the demand side, as with generics, procurement has become increasingly centralized. What began with Wuhan’s 2020 insulin VBP pilot has progressed to the current Anhui-led national biologics alliance procurement for monoclonal antibodies. Biosimilar VBP is clearly expanding—shifting from regional pilots to national programs, and from simpler to increasingly complex biologics.
Yet biosimilars differ markedly from generics — their scientific and regulatory complexity, clinical uncertainties, and distinct pricing and uptake dynamics all raise important questions for VBP design and implementation. For example:
• Generic VBP has been heavily cost-driven, with competition at times pushing prices to levels that are unsustainable for manufacturers.
Will biosimilar VBPs follow the same trajectory, or will policymakers account for the manufacturing complexities and unique clinical attributes of biosimilars?
• Just as GCE underpins generic VBP, biosimilar interchangeability is fundamental to both VBP implementation and clinical adoption.
How are policymakers addressing concerns around efficacy, safety, immunogenicity, and indication extrapolation to build the clinical confidence essential for achieving policy goals?
This article is the first in our Biosimilar Policy Series. It examines China’s evolving biosimilar VBP landscape—policy readiness, emerging procurement rules, pricing implications, and signals from the just-concluded 11th batch of generic NVBP that point to the direction of future biosimilar VBP. Subsequent articles will explore further policy levers to boost supply, stimulate demand, and strengthen the broader biosimilar market. Ultimately, we assess what these developments mean for innovative drug makers and their lifecycle-management strategies in China’s rapidly shifting environment.
1. NHSA’s Dual-Track Policy Approach to Biosimilar Management
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