When is the expected commercial launch in Europe, and what potential reimbursement or payer hurdles could delay adoption?

Expected commercial launch

The European Commission’s approval was announced on 21 August 2025. In the biosimilar space, companies typically need 2‑3 months to complete post‑approval logistics (manufacturing ramp‑up, distribution contracts, and national‑level registration filings). Given Alvotech’s and Advanz Pharma’s existing commercial infrastructure, the pair are likely to target a Q4 2025 launch (October‑December 2025) or, at the latest, early 2026 for the first European markets.

Reimbursement / payer hurdles that could slow adoption

1. National HTA and price‑negotiation cycles – Most EU member states run a health‑technology assessment (HTA) or price‑reimbursement process that can take 3‑6 months after the EMA/EC decision. If Alvotech/Advanz seek a price‑point that is significantly below the reference product (Eylea®), some payers may demand additional real‑world‑evidence (RWE) on switching safety, especially for ophthalmology where clinicians are cautious about biosimilar transitions. Delays in these negotiations could push the first market entry out of the planned Q4 window.

2. Bundling and tender frameworks – Countries such as Germany, Italy, and Spain still use volume‑based tenders for ophthalmology biologics. Alvotech will need to win a tender against the originator and other biosimilars. If the tender calendar does not line up with the Q4 launch, the product could be held back until the next tender round (often early 2026).

3. Payer‑level formulary restrictions – Some health systems (e.g., the UK’s NHS) have “step‑therapy” policies that require patients to fail on the reference product before a biosimilar can be prescribed. This can limit early uptake and force a slower, physician‑driven conversion process.

Trading implications

• Short‑term catalyst: The approval announcement already produced a modest upside (+3‑5 %). A typical post‑approval “sell‑the‑news” pull‑back can be expected in the next 1‑2 weeks, offering a buying opportunity if the broader market remains supportive of the biosimilar narrative.
• Key watch‑list: Monitor HTA outcomes in France (CEESP), Germany (G‑KV), and the UK (NICE). A positive reimbursement decision in any of these markets will likely trigger a secondary rally, while a protracted negotiation could expose the stock to downside pressure.
• Positioning: A light‑to‑moderate long position on Alvotech (ALVO) and Advanz Pharma (ADVAN) can be justified on the upside of a Q4/early‑2026 launch, provided you keep a stop‑loss near the recent post‑approval low (≈ $2.30 for ALVO) to guard against any unexpected payer setbacks. If tender or HTA news turns negative, consider a partial hedge or a short‑term exit until the next tender cycle.