The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) decided to harmonise EU position on interchangeability of biological medicines by issuing a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
Until now, EU biosimilars interchangeability was managed at national level.
What are biosimilars?
A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called “reference medicine”) and which work just as well in patients.
Biosimilar medicines are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. EMA is responsible for evaluating the majority of the applications to market biosimilars in the EU.
The applicant of a proposed biosimilar product generates a large amount of data comparing the proposed product to the EMA-approved reference product in order to demonstrate biosimilarity.
Biosimilarity to the reference biological medicine must be demonstrated in terms of structure, biological activity andefficacy, safety and immunogenicity profile.
What is a biological medicine?
A biological medicine is a medicine whose active substance (the substance responsible for the activity of a medicine) is made by a living organism (ex. human, animals, microorganisms such as bacteria or yeast) and are often produced by cutting-edge technology.
Biologic drugs are used for the treatment of numerous diseases and conditions such as diabetes, rheumatoid arthritis, psoriasis, Crohn's disease, various cancers, leukaemia, haemophilia...
Examples of biological medicines include recombinant proteins, medicinal products derived from human blood and human plasma, monoclonal antibodies and immunological medicinal products.
Because there is natural variability in biologicals, it is not possible to develop an identical copy of the reference product. Indeed, even molecules of the reference product can have small differences.
Are biosimilars generics?
A biosimilar is not a generic of a biological medicine:
- The raw materials used, the production processes, the mechanisms of action and the marketing authorisation procedures are different in biosimilars and generics.
- Generic drugs and the correspondent brand drug (the reference medicine) have the same active substance(s) which is/are small molecules rather easy to copy and reproduce.
- Biologics are cultured from living organisms, and therefore they are generally large and complex molecules not easily reproduced and their manufacture is often more complex.
Both biosimilar and generic drugs contribute to reduce the financial burden on the healthcare system.
Once on the marked, the safety of all medicines including biosimilars is monitored continuously.
What is interchangeability?
Interchangeability is the medical act of replacing a medicine for another medicine that is expected to have the same clinical effect, performed at the prescriber's initiative and with the approval of the patient.
Interchangeability can take place at any time during treatment.
This definition does not include the substitution by the pharmacist (without consulting the prescriber) which is the responsibility of the individual member states.
In France, it is possible to change a biological medicine with another one included in the list of biosimilar medicines (ANSM). In addition, interchangeability must meet the following three conditions:
- the patient must be informed, and his/her agreement must be obtained
- appropriate clinical monitoring must be carried out during the treatment
- traceability of the products concerned must be ensured
In France, the substitution at the pharmacy level of a biological medicinal product by another on the ANSM's list of biosimilar medicinal products is currently not possible.