Biosimilar development in Europe just took a decisive step. Following its reflection paper on a tailored clinical approach, the EMA has confirmed that it no longer expects a comparative efficacy study (CES) to approve biosimilars that can be thoroughly characterised with modern analytical methods. For most new biosimilars, that removes the single largest and most expensive part of the traditional development programme.
From comparative efficacy studies to a tailored approach
The scientific argument is that advances in analytical characterisation, together with pharmacokinetic (PK) data, can be sufficient to demonstrate biosimilarity when a molecule is well understood. Where physicochemical and functional comparability is convincingly shown, a large clinical efficacy trial adds little. The EMA expects this tailored approach to apply to the majority of biosimilars, shortening timelines and lowering the cost of bringing competition to the market.
Interchangeability is already settled in the EU
On the clinical-use side, the position has been clear since the EMA and the Heads of Medicines Agencies (HMA) issued their joint statement: once a biosimilar is approved in the EU, it is interchangeable. That means the biosimilar can be used in place of its reference product, and one biosimilar can be replaced by another of the same reference product, without additional systematic switch studies. Whether a pharmacist may substitute at the counter, however, is decided by each Member State, not by the EMA.
What this means for sponsors
A leaner clinical package changes the business case. Development becomes faster and less capital-intensive, but the analytical and PK evidence must be genuinely robust, because more regulatory weight now rests on it. Companies should revisit their target product profiles, confirm early with regulators that a tailored package is acceptable for their molecule, and make sure their comparability strategy is watertight.
The competitive picture
Cheaper, faster development should mean more biosimilars reaching patients and sharper price competition. For originators, it compresses the window of exclusivity that follows patent expiry. For payers and health systems, it strengthens an already powerful lever for controlling biologics spend.
PQRA advises biosimilar developers on EU regulatory strategy — from comparability planning and scientific advice through the marketing authorisation application. If you are reshaping a programme around the tailored clinical approach, we can help you build a package regulators will accept.
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