Oncology biosimilars in Europe

Europe has played a defining role in the development of biosimilar medicines. In 2006, the European Union became the first region to establish a regulatory framework for biosimilars. Twenty years later, these medicines are an established part of efforts to widen access to biological treatments and manage healthcare expenditure.

Oncology has been central to this progress. Biosimilars referencing established cancer therapies such as bevacizumab, rituximab and trastuzumab are available across European markets. Their use shows that biosimilar competition can become part of routine cancer care.¹

The market is now entering its next phase. More biologics are approaching loss of protection, scientific methods for demonstrating biosimilarity are advancing and regulators are reconsidering the clinical evidence required for some products. Yet regulatory approval alone does not secure uptake or commercial sustainability.

European regulatory requirements continue to evolve

EU biosimilar development is based on a comprehensive comparability exercise. Developers must demonstrate that a proposed biosimilar is highly similar to its reference medicine, with no clinically meaningful differences in quality, safety or efficacy. The programme places particular emphasis on analytical and functional characterisation, supported by clinical evidence that resolves remaining uncertainty.

A significant recent development is the European Medicines Agency’s reflection paper on a tailored clinical approach to biosimilar development. Following public consultation in 2025, EMA adopted the paper in March 2026.²,³ It recognises that, for well-characterised biological substances, advanced analytical methods and accumulated regulatory experience may provide a more sensitive assessment of biosimilarity than a comparative efficacy study. Where analytical comparability, pharmacokinetic evidence and an appropriate safety assessment address residual uncertainty, a comparative efficacy study may not be required.³

This is not a general removal of clinical evidence requirements. The approach applies to well-characterised biologics and each development programme requires a product-specific justification. Developers must consider the molecule’s complexity, mechanism of action, analytical package and the feasibility of a sufficiently sensitive pharmacokinetic study. This distinction is particularly important for the next generation of complex oncology biologics. Early scientific advice can help sponsors align the evidence strategy with regulatory expectations before committing to a development plan.

EMA has since begun the next stage of regulatory modernisation. In July 2026, it released a concept paper proposing a revision of the overarching Guideline on similar biological medicinal products. The revision is intended to reflect the March 2026 reflection paper, work on ICH M18 and changes expected from the new EU pharmaceutical legislation. The consultation is open until 31 October 2026. This is a proposed revision rather than final guidance, but it signals that the tailored clinical approach may be incorporated into the EU’s core biosimilar framework.⁴

In the UK, the Medicines and Healthcare products Regulatory Agency last updated its biosimilar licensing guidance on 27 February 2025. The guidance reflects the Windsor Framework and states that, once authorised, a biosimilar is considered interchangeable with its reference product and with another biosimilar to the same reference product. Developers planning parallel EU and UK strategies should assess the requirements for each route rather than assume that one evidence package will address every procedural consideration.⁵,⁶

A mature but fragmented European market

Europe offers extensive regulatory, clinical and commercial experience with biosimilars. EMA’s Committee for Medicinal Products for Human Use issued positive opinions for 41 biosimilars in 2025, the highest number in a single year. Denosumab accounted for 56% of those positive opinions, indicating both strong activity and substantial concentration around highly competitive targets.⁷

After authorisation, a biosimilar enters a fragmented access environment. Pricing, reimbursement, procurement, prescribing and switching policies are determined nationally or, in some countries, regionally. Uptake can therefore differ markedly between EU Member States, even when products share the same centralised marketing authorisation.

Hospital tendering is especially important for oncology biosimilars. A 2025 European market review identified tendering systems in 26 of the 29 countries assessed. Most tenders were based on the active substance, allowing biosimilars to compete within an established procurement category.¹

Tendering can support rapid uptake, but it also creates commercial pressure. Single-winner tenders remain common and price is often the main award criterion. Limited visibility of minimum or maximum purchasing volumes can complicate manufacturing and supply planning. Excessive price erosion may also reduce the incentive to maintain products or invest in biosimilars for smaller patient populations.

Continuing barriers to oncology biosimilar adoption

Healthcare professional and patient confidence remains important. Some stakeholders continue to question switching, immunogenicity or whether an abbreviated development pathway means lower standards. Clear communication is needed to explain that the biosimilar pathway is not a shortcut. It is a scientifically tailored approach that focuses on demonstrating similarity to an already well-characterised reference medicine.

Robust pharmacovigilance and real-world evidence can reinforce confidence after approval. An Italian study cited in previous ICON research used real-world data from patients treated with biosimilar rituximab and found that switching from the reference product did not increase adverse drug reactions.⁸

Commercial viability presents another challenge. Oncology biologics can be technically difficult and expensive to manufacture. Developers must evaluate the eligible population, expected competition, analytical complexity, development requirements, supply obligations and achievable pricing. A programme may be scientifically feasible without supporting a sustainable commercial case.

Why developers should consider Europe

Despite these challenges, Europe offers several strategic advantages for oncology biosimilar developers:

A mature regulatory framework with extensive scientific assessment experience. EMA’s tailored clinical approach may enable more focused programmes where robust analytical and pharmacokinetic evidence can reduce the need for comparative efficacy studies.
Established use within healthcare delivery. Regulators, payers, procurement bodies and many clinicians have practical experience with biosimilars.
A centralised EU marketing authorisation, which provides one regulatory assessment and broad geographic reach. Country-specific access planning is still essential.
Established hospital procurement routes through which oncology biosimilars can compete. Success depends on understanding tender design, pricing expectations and supply commitments in each target market.
Future portfolio opportunities as more biologics approach loss of protection. EMA has cautioned that several biologics nearing loss of data protection have no biosimilar development activity, suggesting potential gaps beyond the most crowded molecules.⁷

For developers based in Asia-Pacific, including companies in India, China and South Korea, Europe may be an important part of an international growth strategy. Entry requires more than adapting a domestic dossier. Sponsors should evaluate EMA expectations, European reference-product sourcing, manufacturing comparability, pharmacokinetic study feasibility and national access conditions early in development.

Planning for the next generation of biosimilars

Europe’s oncology biosimilar market is attractive but demanding. Its mature regulatory framework, established adoption, broad geographic reach and future portfolio opportunities create a strong case for investment. At the same time, fragmented access pathways, price competition and supply commitments require disciplined planning.

Success depends on integrating analytical, clinical, regulatory, manufacturing and market access strategies from the outset. Sponsors that select targets carefully, obtain early scientific advice and prepare for national market conditions will be better positioned to translate loss-of-protection opportunities into sustainable competition and broader access to cancer treatment.