The Return of Biosimilar Substitution in France

Biotech 3 min
March 28, 2022

Every year the Social Security Financing Law for 2022 (LFSS 2022) introduces several measures resulting in important changes for the life sciences sector and the health insurance system. One of the recent changes of note include the reintroduction of biosimilar substitution, which will allow pharmacists to substitute a biosimilar for the prescribed (reference) biological under certain conditions.

Similar legislation enabling biosimilar substitution has existed previously in France. Introduced by the Social Security Financing law for 2014, the provision that allows substitution of branded medicinal products for generics had been adapted to extend to biosimilars allowing the pharmacists to substitute biological medicines. However, given the difficulties encountered in implementing the terms of this substitution, the Social Security Financing law for 2020 cancelled this measure.

Aware of the source of savings that the development of biosimilars could represent for health insurance, the right to substitute biosimilars was reintroduced by the Social Security Financing law for 2022 under a new dedicated article L. 5125-23-2 of the French public health code.

Pharmacists will now be able to substitute a biological medicine with a biosimilar of the same “similar biologic group” under the following conditions:

  • The biosimilar medicine delivered by the pharmacist belongs to the same “similar biologic group” as the prescribed biological medicine;
  • The “similar biological group” is registered on a list set by an order of the ministers responsible for health and social security, following the assessment of the French Medicines Agency (Agence nationale de sécurité du medicament et des produits de santé);
  • The substitution is possible only if the prescribing physician has not marked the prescription as “non-substitutable” and justified this statement on the prescription, based on the patient’s medical state;
  • If the prescribed medicinal product is registered on the list of reimbursable products, the substitution must not result in expenses for the health insurance system that are greater than the expenses that would have resulted if the most expensive biosimilar medicine in the same group had been delivered.

The pharmacist will have to write the name of the biosimilar they have dispensed on the prescription and inform both the prescribing physician and the patient of this substitution.

However, substitution is only expected to occur in practice after the publication of a separate order that should determine the details for substitution of biosimilars, potentially including specific conditions regarding biosimilars that have fewer approved indications than their reference medicine.

The upcoming order will also determine the similar biologic groups that will be authorised for substitution. Indeed, biosimilar substitution is to be implemented gradually in order to take into consideration the issues of patient safety, acceptability by professionals, patients and all stakeholders, as well as compliance with all other schemes encouraging the use of biosimilars.

In the first instance, it has been mentioned that substitution will be limited to the following two biological groups: somatropin and pegfilgrastim.

The introduction of biosimilars is considered by many as a step forward in the healthcare system since it serves two purposes:

  • Facilitating access to care as the increase of the number of available biological medicines helps limit supply tensions and prevent stockouts, ensuring that patients continue to have access to their treatments.
  • Stimulating competition and supporting the growth of industries specialising in this field, as substitutions are expected to generate significant savings for the health insurance system by increasing the use of biosimilar medicines that are cheaper than their reference medicines, while guaranteeing equal safety and quality of treatments.

Implementing decrees are expected in the second half of 2022, depending on the negotiations between the different parties involved, making biosimilar substitution not only legal, but also effective.

 

 

Written by
Johanna Harelimana
Johanna Harelimana
I am a junior associate, with experience advising clients on regulatory matters across several sectors, especially in life sciences, food and beverages, and environmental sectors. I currently offer both French and international clients legal advice on product's qualification, clinical trials, market access, price and reimbursement, anti-gift regulation, advertising and promotion, e-health (including telemedicine), as well as drafting contracts (distribution, professional services, clinical trial agreements, etc). I also assist with regulatory advice on other products such as cosmetics, biocide, phytopharmaceuticals and novel food.

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