The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued on 19 September 2022 a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Interchangeability in this context means that the reference medicine can be substituted by a biosimilar without a patient experiencing any changes in the clinical effect, however, this decision does not include automatic substitution at the pharmacy level.
In the US, an interchangeable medicine is a biosimilar to the reference medicine and can be expected to produce the same clinical result as the reference medicine in any given patient . Each state has already passed laws that permit or require pharmacists to dispense interchangeable biosimilars in certain situations, but they do not do so without knowledge of the physician.
The EU approved the first biosimilar in 2006. Europe has the world’s largest biosimilar market, and growing annually . Up to now, 86 biosimilars have been approved by EMA.
In the joint EMA-HMA statement on interchangeability, the EU experts on biosimilar medicines (Biosimilar Medicines Working Party or BMWP) and HMA’s Working Group of Biosimilars explained the rationale for considering biosimilars approved in the EU as interchangeable from a scientific perspective. This statement was endorsed by EMA’s Committee for Medicinal Products for Human Use (CHMP) and the Biologics Working Party (BWP) on 22 July 2022.
Scientific rationale for the joint EMA-HMA statement on interchangeability
- The EU regulatory network has gained profound understanding of biosimilars after reviewing more than 100 biosimilar candidate submissions, and authorizing biosimilars and monitoring their safety for over 15 years.
- Switching between biological medicinal products manufactured and commercialised by different companies has become common in clinical practice, which shows that biosimilars approved through EMA can be used as safely and effectively in all their approved indications as other biological medicines.
- Approved biosimilars have demonstrated comparable efficacy, safety and immunogenicity compared with their reference products. Thus, additional systematic switch studies are not required to support the interchangeability at prescriber level for EU approved biosimilar.
Member States will continue to decide which biological medicines are available for prescribing in each territory and whether automatic substitution (the practice of dispensing one medicine instead of another without consulting the prescriber) is allowed at pharmacy level.
What does the designation of interchangeability for biosimilars in the US mean?
Benefits of innovative biologicals and biosimilars for patients and health systems
Are systematic switch studies for biosimilars necessary?
Biosimilars approved in Europe
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1. GaBI Online - Generics and Biosimilars Initiative. Approaches to streamline biosimilar interchangeable programmes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/reports/approaches-to-streamline-biosimilar-interchangeable-programmes
2. GaBI Online - Generics and Biosimilars Initiative. Sustainable biosimilar policies in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 23]. Available from: www.gabionline.net/biosimilars/research/Sustainable-biosimilar-policies-in-Europe
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