A biosimilar medicine is one that demonstrates high similarity to another biological medicinal product that has already been approved- this is also known as the ‘reference product’. Interchangeability refers to using one medicinal product instead of another provided the therapeutic intent is the same. In this context, interchangeability is the medicinal product being substituted by a biosimilar that would produce the same clinical effect.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a statement together, based on the analysis of over a million patient-treatment years of safety which did not raise safety concerns, that if a biosimilar is granted approval in the EU it can be used instead of its reference product, or vice versa, or be replaced by another biosimilar of the same reference product. While several Member States already practice the interchangeable use of biosimilars, the joint statement establishes and facilitates harmonization for the EU approach as:
- it provides healthcare professionals with more clarity
- it helps provide better access to biological medicinal products to patients across the EU for treatment of cancer, diabetes, and rheumatic diseases
Earlier, EMA-approved biosimilars could be interchanged provided permission was granted from the relevant national regulatory agency. Though, scientifically, biosimilar interchangeability was considered acceptable and did not raise major issues, EMA had not yet established any recommendation on biosimilar interchangeability.
The EMA has already approved 86 biosimilar medicinal products since 2006. These include polysaccharides such as enoxaparin sodium; growth factors such as epoetin & filgrastim; hormones such as insulin glargine & somatropin; fusion proteins such as etanercept; and monoclonal antibodies such as adalimumab. Clinical practice data has shown that these biosimilars are comparable to their reference products in terms of efficacy, safety, and immunogenicity and therefore can be interchanged according to EMA’s Executive Director, Emer Cooke. This statement was endorsed by the Committee for Medicinal Products for Human Use (CHMP) on the 22nd July 2022, and published on the 19th September with the scientific rationale. After reviewing over one hundred biosimilar candidate submissions and evaluating their post-market safety profile the interchangeability of EU-approved biosimilars is now permitted. Additional systematic switch studies are no longer required to support interchangeability at prescriber level.
The decision on pharmacy-level substitution without consulting the patient lies with the individual Member States.
A step for the EU and a leap for the world:
In addition to EU Member States, countries around the world that follow and incorporate the EMA guidelines would benefit from adopting these changes. For example, the GCC region faces challenges in the harmonization on regulatory approval and biosimilar interchangeability with different countries having their own regulations. This delays patient access to biological products that could treat a variety of complex diseases that significantly contribute towards quality of life. By issuing the joint statement, the EMA and HMA have taken a step forward to ensure that patients have better access to better and more affordable treatment options.
References and Further Reading:
- European Medicines Agency: Biosimilar medicines can be interchanged
- European Medicines Agency: Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU
- Varied approach to interchangeability across the MENA region
- Biosimilars in the EU: Information guide for healthcare professionals