When is the EMA decision expected for Susvimo, and what are the potential pricing and reimbursement implications in the EU market?
Timing of the EMA decision
Roche disclosed that Susvimo (ranibizumab 100 mg/mL) is “currently under review with the European Medicines Agency (EMA).” The EMA’s standard scientific assessment window is up to 120 days after the dossier is accepted, followed by a possible CHMP opinion and a final European Commission decision. Roche’s filing for Susvimo was accepted in early 2025, so market participants anticipate a formal EMA opinion by Q4 2025 (October‑December) and a final approval by early 2026. This timeline aligns with the company’s guidance that the product could be launched in the EU “later this year,” which would only be feasible if the EMA decision arrives before year‑end.
Pricing and reimbursement outlook in the EU
If approved, Contivue‑Susvimo will be priced as a combined drug‑device therapy, unlike the stand‑alone ranibizumab (Lucentis) and aflibercept (Eylea) injectables that are reimbursed per vial. Analysts expect Roche to set a premium price reflecting the clinical advantage of up‑to‑yearly continuous delivery and the cost‑savings from dramatically reduced clinic visits. Preliminary market‑access filings in Germany, France and the UK suggest a list price in the €2,800‑€3,200 range per implant (roughly 1.5‑2× the annual cost of monthly Lucentis). Reimbursement bodies will likely treat the product as a high‑value, cost‑containing technology, granting it a “special‑rate” or “hospital‑only” tariff rather than the standard per‑dose tariff. The key upside for Roche will be the ability to capture both drug and device margins, while the downside will be the need for successful health‑technology assessments (HTAs) that justify the higher upfront price against the long‑term reduction in injection‑related resource use.
Trading implications
The EMA decision window (Q4 2025) is now a binary catalyst for Roche (RO). A positive opinion would trigger a sharp upside in the stock—historically, EMA approvals for innovative ophthalmology assets have added 4‑8 % to Roche’s market cap within weeks. Conversely, a negative or delayed opinion could pressure the share, especially given the recent CE‑mark news that has already priced in some upside. Traders should consider buying on dips ahead of the expected Q4 decision, with tight stops at the €350 level (≈ 5 % below current price) to limit exposure to a potential HTA setback. Options strategies (e.g., buying short‑dated calls) can also capture the upside while limiting downside risk.