Legal news
Biosimilar medicines - Recent regulatory developments in the European Union and France
What is a biosimilar product ?
A biosimilar is a biological medicine (i.e., a medicine whose active substance is made by a living organism) highly similar to another already approved biological medicine (the « reference medicine »EMA, [1]) .
According to the European Medicines Agency (« EMA »), biosimilar medicines have become major therapeutic options, because they improve patient access to essential treatments [2] (e.g., for patients with chronic conditions such as diabetes, autoimmune disease and cancers) [3].
This interest in biosimilar products has led to significant changes at many levels.
May pharmacists substitute biosimilar medicines to the reference medicine ?
At a European level, the EMA and national health authorities expressed in April 2023 the position that biosimilar medicines approved in the European Union are interchangeable from a scientific perspective [4].
In France, the Parliament has been working on the substitution of reference medicines by biosimilar products since 2013. As of now, the French Agency in charge of regulating medicines (« ANSM ») has gradually allowed in 2022 the substitution by biosimilar medicines of a limited sample of reference medicines (i.e., Neupogen and Neulasta).
In 2023, the French Government decided, especially in light of the most recent EU developments, to go a step further by making the substitution of reference medicines by biosimilar medicines as automatic as possible.
However, the law that was finally adopted thanks to this initiative is more restrictive :
- The principle remains that a pharmacist may deliver a biosimilar medicine in place of its reference product only if the reference medicine and the biosimilar one belong to the same biological group, and if this group is mentioned in a ministerial order (the list of substitutable biological groups).
- By derogation to this principle, the Ministry for health may authorize pharmacists to deliver a biosimilar medicine in place of its reference product if, two years after the start of the reimbursement in France of a first biosimilar product, the biological group to which the products belong is still not mentioned in the list of substitutable biological groups.
- Before the expiry of this 2-year-long period, the ANSM may issue an opinion to the contrary. In addition, the ANSM will have until 31 December 2024 to issue said opinion in relation to biosimilar products that were already reimbursed before the publication of this law.
Following the adoption of this law, the ANSM created on 15 February 2024 a committee made up of representatives of associations of patients and healthcare practitioners. The ANSM will provide opinions on the substitution of each biological group based on the recommendations and work of this committee.
How are biosimilar medicines approved in the EU ?
As of now, biosimilar medicines are approved according to the same standards of quality, safety and efficacy that apply to biological medicines approved in the EU. In particular, developers shall produce comprehensive comparability studies [5].
On 1 February 2024, the EMA published a concept paper to discuss the opportunity of a tailored clinical approach in relation to the development of new biosimilar medicines [6]. To keep the biosimilar pathway attractive for laboratories, the EMA considers that it is necessary to revisit the need for clinical efficacy trials for biosimilar medicines.
This paper is a very preliminary paper, subject to public consultation, which has no regulatory power. However, it could lead to significant changes in European regulations and legislations in the future.
TO BE CONTINUED…
[2] EMA, Concept paper for the development of a reflection paper on a tailored clinical approach in Biosimilar development, 24 November 2023
[4] EMA and HMA, Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU, last updated in April 2023
[6] EMA, Concept paper for the development of a reflection paper on a tailored clinical approach in Biosimilar development, 24 November 2023