Biosimilars have saved European health systems tens of billions of euros — yet uptake remains uneven, and market access is about far more than offering the lowest price.
A biosimilar is a biological medicine highly similar to an already-approved reference biologic. Since a landmark joint statement by the EMA and the Heads of Medicines Agencies in September 2022, biosimilars approved in the EU are considered interchangeable with their reference product. Importantly, this is a scientific position — whether automatic pharmacy-level substitution is allowed remains a national decision.
The savings — and the paradox
Biosimilar competition has generated cumulative list-price savings in the order of tens of billions of euros across Europe, funding additional treatment for many more patients. Yet biosimilars still account for only a modest share of biologics spending, with wide variation between countries and molecules. Uptake is strongest where tenders, quotas and prescriber incentives actively support it.
What holds uptake back
- Lingering confidence gaps among some prescribers and patients, despite growing positive sentiment.
- Procurement complexity and single-winner tenders that can squeeze supply.
- Policy variability between countries on substitution and switching.
- A structural risk: a share of biologics losing exclusivity may face no biosimilar competition at all, forgoing potential savings.
The price-spiral risk
Aggressive price cuts, reference pricing and clawbacks drive deep discounts, but can push prices into a downward spiral that discourages manufacturers from entering smaller markets — ultimately undermining the savings they were meant to secure. To ease development, the EMA has also moved to streamline biosimilar requirements, adopting a reflection paper in 2026 that can reduce or remove comparative efficacy studies where analytical and PK data are robust.
The Greek picture
Greece’s market is shaped by clawback and rebate mechanisms that repay spending above a capped pharmaceutical budget. High clawback exposure disproportionately squeezes low-margin biosimilars, blunting the very savings incentive they offer — making a smart access and tender strategy essential.
How PQRA helps
PQRA supports biosimilar pricing strategy, tender positioning and reimbursement submissions in Greece — helping you win access sustainably, not just cheaply.
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