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Biosimilar Market Access in the EU: Turning Approval into Uptake
Approval is only the start. How tenders, interchangeability policy and payer evidence decide whether a biosimilar actually gains share.
How Medicines Are Priced in Greece: A Practical Guide
Pricing a medicine in Greece is not a negotiation in the usual sense — it is largely a calculation, driven by the prices of other[…]
Real-World Evidence: From Nice-to-Have to Decision-Maker
The randomised controlled trial remains the gold standard — but it no longer stands alone. Real-world evidence is increasingly shaping both regulatory approval and reimbursement[…]
Biosimilars in Europe: Interchangeability and the New Tailored Clinical Approach
By 2026 the European biosimilar framework has matured from cautious, case-by-case review into one of the most confident regulatory systems in the world — and[…]
Joint Clinical Assessment for Gene Therapies: In Scope from Day One
Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. As advanced therapy[…]
Joint Clinical Assessment for Rare Disease Therapies: Preparing for 2028
The EU Joint Clinical Assessment (JCA) will extend to orphan medicines from January 2028, drawing rare disease therapies into a single, EU-wide clinical assessment. For[…]
Real-World Evidence in EU Medicines Regulation: From Nice-to-Have to Core
Real-world evidence (RWE) has moved from the margins of EU medicines regulation to its core. Through initiatives such as DARWIN EU, the European Medicines Agency[…]
External Reference Pricing in Greece: How Prices Are Set and Reviewed
External reference pricing (ERP) sits at the heart of how medicine prices are set in Greece. For any company launching a product, understanding how the[…]
The EU Pharma Package: A New Baseline for Exclusivity and Access
After more than two years of negotiation, the European Union has settled the text of its new pharmaceutical legislation — the most significant overhaul of[…]
Clawback and Rebates in Greece: The 2026-2030 Framework
Clawback is the single biggest commercial variable in the Greek pharmaceutical market. The rules for the rest of this decade were quietly rewritten in late[…]