EU ruling can bolster competition in medicines markets, say experts

Gareth Morgan and Josie Miller of Pinsent Masons were commenting after the Court of Justice of the EU (CJEU) ruled that medicines developed with reference to biological medicines but from a chemical synthesis may, when certain conditions are met, be treated as generics, rather than biosimilars, for regulatory approval purposes under EU law.

In the pharmaceutical market, first-of-their-kind medicines commonly enjoy monopolies for a period owing to applicable intellectual property rights and/or regulatory protections. Once those rights and protections expire, it is open to other manufacturers to develop competing products that rely on the same technologies, processes and/or data, for the purposes of obtaining marketing authorisation for their products. This system seeks to balance incentives to innovate with the benefits competition can bring, such as around the price of medicines.

There are two main types of competitor products. Generic medicines are exact chemical copies of small‑molecule originator drugs; biosimilars are medicines based on originator biologics, which are drugs that contain active substances produced in living systems, such as mammalian cells. Biologics are often large, complex molecules with a small degree of inherent heterogeneity because of the manner in which they are produced.

Because biosimilars are not exactly the same as the originator biologics they are based on, the regulatory system distinguishes between them and generics, to date imposing more stringent requirements on biosimilar manufacturers for obtaining marketing authorisation for their products and a standalone abridged approval pathway in Article 10(4) of the Medicinal Products Directive.

Under EU law, for example, generic medicine manufacturers are exempt from requirements to undertake their own pre-clinical testing and clinical trials – they can rely on the work undertaken by originators in this regard when applying for marketing authorisation, using the so-called “generic procedure” in Article 10(1) of the Medicinal Products Directive. On the other hand, biosimilar manufacturers have been required to submit the results of their own clinical efficacy studies to regulators to demonstrate ‘biosimilarity’ with originator biologics, though the policy on this has been shifting in the EU and US.

In a case referred to it from France, the CJEU was asked to determine whether the generic procedure for obtaining marketing authorisation is open to chemically synthesised medicines in the scenario where those products are referenced against a biologic product. The CJEU ruled that it can, provided that the statutory criteria for generic classification are satisfied. 

In its ruling, the CJEU confirmed that the classification of a reference product as “biological” does not, of itself, require follow-on products to be authorised as biosimilars. EU pharmaceutical law focuses on therapeutic equivalence and regulatory criteria, rather than manufacturing techniques considered in isolation. 

In addition, the CJEU confirmed that national courts across the EU are competent to judicially review marketing authorisations granted following a decentralised procedure, including whether the conditions for generic authorisation in EU law have been satisfied, in the interests of public health protection. This represents an expansion in scope of what has historically been understood from the Synthon and Astellas decisions in CJEU case law. It increases the grounds on which generic marketing authorisations can be challenged in the courts of member states.

The CJEU confirmed that chemically synthesised peptides, if structurally identical to a reference biological product, can now be authorised as generic versions of biological reference products, providing they meet the set criteria. This means that the product must have the same qualitative and quantitative composition in active substances as the reference product. It must also have the same pharmaceutical form, and must have demonstrated bioequivalence – meaning that it is equivalent in the rate and extent to which the active ingredient becomes available at the site of drug action – through appropriate studies.

Morgan said: “This is an important decision – it essentially streamlines the approval process for synthetic follow‑on peptides by allowing them to access the simpler generic authorisation pathway. This is also a refreshing vindication of the EMA’s science-driven approach to biologics.”

“This means that such products may be able to enter the European market quicker, increasing competition, and is therefore a positive outcome for generic medicines manufacturers, national health funds, and patients,” he said.

Miller added: “This judgment provides important clarification for the pharmaceutical sector, potentially reducing development burdens and accelerating market entry where therapeutic equivalence can be demonstrated. At the same time, the decision underscores the continuing role of national courts in safeguarding public health through judicial review, even within harmonised EU authorisation procedures.”

The CJEU issued its ruling in the context of a dispute that had arisen over a decision taken by the French medicines agency (ANSM) to grant pharmaceutical company Biogaran SAS a marketing authorisation for a generic version of Forsteo, a biological medicine developed by Eli Lilly which is used in the treatment of osteoporosis. While Biogaran’s product contains teriparatide, like Forsteo does, and is presented in the same pharmaceutical form as Eli Lilly’s product, its active substance is produced by solid‑phase peptide synthesis, rather than from a biological source.

Both EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS challenged the ANSM’s decision. They had earlier obtained marketing authorisation for their own biosimilar – i.e. biologically produced – rivals to Forsteo. They have argued that Biogran’s product did not meet the criteria for being assessed as a generic medicine under the regulatory regime.

It will now be for the Conseil d’État in France to rule on the dispute in line with this CJEU ruling.