Amsterdam: EMA and the Heads of Medications Businesses (HMA) have issued a joint remark confirming that biosimilar medications authorized within the Ecu Union (EU) are interchangeable with their reference medication or with an similar biosimilar.
Whilst interchangeable use of biosimilars is already practiced in lots of Member States, this joint place harmonises the EU manner. It brings extra readability for healthcare pros and thus is helping extra sufferers to have get entry to to organic medications around the EU.
Interchangeability on this context signifies that the reference medication may also be substituted through a biosimilar and not using a affected person experiencing any adjustments within the scientific impact.
“EMA has approved 86 biosimilar medicines since 2006. These medicines have been thoroughly reviewed and monitored over the past 15 years and the experience from clinical practice has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference products and are therefore interchangeable”, mentioned Emer Cooke, Government Director, EMA.
The remark, drafted through EU professionals from the Biosimilar Running Birthday party and the Heads of Medications Businesses Running Staff of Biosimilars, was once recommended through EMA’s human medications committee, the CHMP, on July 22, 2022.
EMA’s place is according to the enjoy received in scientific observe, the place it has turn out to be commonplace that docs transfer sufferers between other organic medicinal merchandise. Licensed biosimilars have demonstrated identical efficacy, protection and immunogenicity when put next with their reference medications, and research of a couple of million patient-treatment years of protection knowledge didn’t lift any protection issues. Thus, EU professionals thought to be that after a biosimilar is granted approval within the EU, it may be used as an alternative of its reference product (or vice versa) or changed through any other biosimilar of the similar reference product.
Choices referring to substitution at pharmacy-level (the observe of shelling out one medication as an alternative of any other with out consulting the prescriber) are controlled through person Member States.
EMA will replace its verbal exchange fabrics on biosimilars for sufferers and healthcare pros to focus on the average place.