A biosimilar is defined by the European Medicines Agency (EMA) as: “a biological medicine highly similar to another biological medicine already approved in the EU (called ‘reference medicine’) in terms of structure, biological activity and efficacy, safety and immunogenicity profile”.
Developers of biosimilars are required to demonstrate through comprehensive comparability studies with the ‘reference’ biological medicine that their biological medicine is highly similar to the reference medicine, notwithstanding natural variability inherent to all biological medicines, and that there are no clinically meaningful differences. Consequently, biosimilar developers can benefit to some extent from the work carried out by the original innovator company, for instance by avoiding unnecessary repetition of clinical trials already carried out with the reference medicine. This streamlined approval process should increase competition, enabling biosimilar alternatives to enter the market at affordable prices for consumers.
A balance must always be struck between encouraging new drug innovations by rewarding innovators and ensuring patient access to medicines at affordable prices, by allowing biosimilar medicines to enter the market.
Innovators need to be able to rely on a robust IP system that adequately protects their assets. While at the same time, various provisions exist that are intended to limit the IP rights of innovators, albeit only in certain specific circumstances, to ensure that the biosimilar industry is able to function effectively and enter the market as soon as patent protection expires.. The Bolar Exemption, SPC Manufacturing Waivers and “Skinny” labelling are all such initiatives.
Bolar exemption: Allows manufacturers of biosimilar medicines to undertake certain acts required for preparing a corresponding marketing authorisation application without infringing on existing patent rights. It permits any studies, tests and trials carried out to show that a biosimilar product is bioequivalent to an approved, patented product, where these acts are required for submitting a marketing authorisation application. The Bolar exemption aims to encourage earlier generic and biosimilar access after expiry of IP rights and to increase availability of more affordable drugs.
SPC manufacturing waiver: Introduces an exception to the protection conferred by an SPC. It applies to all SPCs filed on or after 1 July 2019. The waiver permits EU-based biosimilar companies to manufacture an SPC-protected product specifically for export to a non-EU country where patent protection does not exist (“export exemption”). In addition, the waiver permits the stockpiling of the SPC-protected product in the EU during the final six months before SPC expiry (“stockpiling exemption”). These measures are intended to ensure that biosimilar manufacturers based in the EU are more effectively able to compete with non-EU-based manufacturers and puts them in a better position to launch in the EU immediately after expiry of the SPC – a practice known as a ‘day 1 launch’.
Skinny labelling: Whereby a biosimilar drug manufacturer can exclude patented uses or indications from their product label when applying for marketing authorisation. This allows them to “carve out” the patented information from the label, thus enabling market entry despite the patent barrier. While elegant on paper, in practice, “cross-label” use often occurs. Healthcare practitioners or pharmacists may write prescriptions with reference to the INN of a drug, with the result that patients can end up receiving a generic version of a drug to treat a patented indication.
Loss of exclusivity: For innovators, once patent protection and regulatory exclusivity periods have expired, developers face a “loss of exclusivity (LoE)”, the point at which biosimilars can freely enter the market. To remedy the potential loss of revenue, innovators may turn to non-patent-related strategies. These may include:
- marketing strategies to preserve brand equity and patient loyalty;
- switching patients to a next-generation or over-the-counter (OTC) version of the product;
- surge pricing to maximise earnings prior to patent expiry; and
- special contracts, such as volume discounts, bundled product offerings and service discounts to incentivise channels to stock or dispense preferred brands and inhibit generic substitution.
Notably, for high-affinity brands, patients often exhibit “stickiness” – a tendency to continue using a specific brand-name medication even after lower-cost biosimilar alternatives become available.
This article was originally published as part of our guide to IP Rights and Exclusivity for Pharma and Biotech in Europe.
Should you wish to discuss anything covered in this article or our wider guide, please reach out to your regular Boult contact.
