Biosimilars in Europe: the exclusivity rules, the pathway and why launch timing differs from small molecules

Same clocks, different race

A biosimilar is a biological medicine shown to be highly similar to an authorised reference biologic, with no clinically meaningful differences. It is authorised under its own article of the pharmaceutical code, almost always centrally, on a dossier of comparative analytical, functional and clinical data rather than a bioequivalence study. The exclusivity clocks are the ones every product has: eight years of data protection and two of market protection from the reference product’s first EU authorisation, the reference product’s patents, and its SPC. What differs is everything around them.

Where the clocks fall for biologics

Data protection rarely bites. Biologics take long to develop and authorise, so the reference product’s regulatory protection usually expires years before its patents and SPC. The date that matters is almost always the SPC date.

SPCs apply to biologics as to any active ingredient: the certificate protects the antibody or protein as authorised, on the strength of the basic patent that claims it. The compound SPC on a monoclonal antibody is the equivalent of the small-molecule compound SPC, and biosimilar launches in Europe cluster on it, usually with several entrants on the same day because development programmes were all aimed at the same date.

The fight is on the other patents. Beyond the basic antibody patent, originators hold patents on manufacturing processes, cell lines, formulations (concentration, excipients, devices), dosing regimens and indications, many filed years after the compound. Because a biologic’s process is part of its identity, process patents carry weight they rarely have for small molecules, and litigation runs on them before and after the SPC date. The Unified Patent Court’s first pharmaceutical injunction cases were biologics, and the eculizumab and evolocumab case notes show both outcomes: biosimilars blocked by an injunction, and a patent revoked then restored on appeal.

The manufacturing waiver matters more for biosimilars than for generics. Since 2019 a company may make an SPC-protected product in the EU for export outside the EU during the SPC, and for stockpiling in the last six months; biosimilar manufacturers with EU plants use it to supply markets where the reference product’s protection has already ended.

Development is the long pole

A generic small molecule can be developed in two to three years; a biosimilar programme takes six to nine, costs an order of magnitude more, and must be running before the SPC date is even certain. That is why biosimilar competition arrives for the largest products only, why the number of entrants is small, and why a change in the SPC date (a paediatric extension granted late, a patent revoked early) has such visible effects on who launches when.

After authorisation: uptake runs differently

Interchangeability. In September 2022 the EMA and the heads of the national agencies stated that biosimilars approved in the EU are interchangeable with their reference product and with each other. Whether a pharmacist may substitute one for another at the counter remains a national decision, and most countries do not allow it or allow it only for specific products. The practical consequence is that biosimilar uptake is driven by prescribers and, above all, by hospital and insurer tenders and switching policies, not by the automatic substitution that moves generic volumes within weeks.

Tenders. For hospital biologics the first tender after the SPC date is the launch; the price set there, often a steep discount for the winner, is the price. Products dispensed in the community follow national reimbursement rules, with gainshare and quota schemes in some countries.

Price erosion is slower and shallower than for generics: fewer entrants, higher costs, and clinicians’ switching caution. It still reaches 50 to 80 per cent on the largest products over a few years.

What it means, by role

For a parallel trader. Biologics are traded, with cold-chain and repackaging constraints and, for centrally authorised products, the parallel distribution notification route. The arrival of biosimilars in a market changes the originator’s price there and removes the import opportunity; the SPC date per country is the signal, and it can differ across Europe by paediatric extensions and by litigation.

For a biosimilar planner. The SPC date is the target, the secondary patent position decides whether launching on it is possible, and the tender calendar decides whether launching on it is worth anything. Clear-the-path litigation two to three years out is the norm, and the UPC now offers a single forum for most of the EU.

For a buyer or payer. Expect launches in clusters on the SPC date, uptake through tenders and switching rather than substitution, and prices that fall in steps at each tender rather than in a Category M-style drop.

MPA Search records the SPC and patent position for biologics as for small molecules, country by country, with the licences and prices alongside; the biosimilar case notes track the disputes that move the dates.