On 14 July 2025, Samsung Bioepis published a whitepaper entitled “Solving the Biosimilar Void in Europe”, which proposes various recommendations for European biosimilar policy reform.
The whitepaper states that the current biosimilar policy environment in Europe needs “improvements to better reflect the value recognition of biosimilars and ultimately support a more sustainable market”. In particular, it identifies challenges that biosimilars face, with “restrictive and misaligned tailored Health Technology Assessment (HTA) and pricing and reimbursement (P&R) processes”; “tendering and cost-containment policies that lead to continuous price erosion” throughout the lifecycle of biosimilars; and polices that hinder sufficient uptake of biosimilars.
Against this background, Samsung Bioepis’ policy recommendations include the following:
- Tailoring and streamlining HTA for biosimilars (eg. taking into account additional benefits of biosimilars, HTA waivers, indication extrapolation and mechanisms for acceleration);
- Avoiding arbitrary price controls for biosimilars at launch (eg. unjustified mandatory discounts) and allowing price discounts to be achieved by market dynamics;
- Ensuring national, regional and local tenders support diversification of supply and fair competition through multi-winner tenders with contract volume shares; transparent and periodic tender opening and a broad set of value criteria considerations; and
- Implementing incentives to healthcare professionals to encourage prescribing and dispensing of biosimilars, based on shared decision making between physicians and patients
The whitepaper considers that “the most important step” is for “policymakers to shift from perceiving biosimilars solely as cost saving tools” and to recognise their “vital role in strengthening market efficiency, patient access and system resilience”.