Blog Big Molecule Watch September 20, 2022

European Regulatory Heads Make Biosimilars Interchangeable

On September 19, 2022, the European Medicines Agency’s (“EMA”) Biosimilar Medicines Working Party (“BMWP”) and the Heads of Medicines Agencies (“HMA”), a network of the heads of the authorities responsible for the regulation of medicinal products for human use in the European Economic Area, issued a Joint Statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.

Interchangeable use of biosimilars is already practiced in many Member States. The Joint Statement harmonizes the EU approach. The Joint Statement notes:

Interchangeability refers to the possibility of exchanging one medicine for another medicine that is expected to have the same clinical effect.

HMA and EMA consider that once a biosimilar is approved in the EU it is interchangeable, which means the biosimilar can be used instead of its reference product (or vice versa) or one biosimilar can be replaced with another biosimilar of the same reference product.

The Joint Statement also clarifies that decisions regarding automatic substitution at pharmacy-level (i.e., dispensing an interchangeable medicine instead of the reference product without consulting the prescriber), will be managed by individual member states.

Until now, the EMA had not released an official position on interchangeability. Per the Joint Statement, “the EU regulatory network has been assessing, authorising and monitoring biosimilars for over 15 years and has gained very profound understanding of biosimilars after reviewing more than one hundred biosimilar candidate submissions, and monitoring their safety once they are placed onto the market. … Considering all the available scientific evidence and the successful experience with biosimilars in clinical practice over the years, the CHMP and all working parties with expertise in biological medicines and biosimilars support that medicines approved as biosimilars in the EU may be prescribed interchangeably. This will allow more patients to have access to biological medicines necessary for treating diseases such as cancer, diabetes and rheumatic diseases.”

The EMA’s position stands in contrast to the FDA’s, which requires that biosimilars must meet additional requirements to be classified as interchangeable.

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