Since 2010 -- when the MEB adopted its first position on biosimilars, which was that patients “must be kept on a biological medicinal product as much as possible if they respond well to it clinically” – the board has since conducted a study of the most recent literature and experiences in the evaluation of biosimilars and deemed “that this strict condition is no longer valid.”
“There is enough evidence to support the use of biosimilars in clinical practice, provided this occurs with caution and under certain conditions,” the MEB, which assesses and monitors the efficacy, risks and quality of human drugs, says in its new position statement.
The exchange between biological medicines -- “regardless of whether they are innovator products or biosimilar medicinal products” -- is now permitted, which essentially deems them to be interchangeable, but only if adequate clinical monitoring is performed and the patient is properly informed, the board says.
The Medicines Evaluation Board has also taken some other positions on biosimilars, including that new patients can be treated with a biosimilar “right away,” though “uncontrolled exchange between biological medicinal products (regardless of whether they are innovator products or biosimilar medicinal products) must be avoided. In other words, a patient must receive adequate clinical monitoring and clear instructions,” the board says.
In addition, if a patient is treated with a biosimilar, detailed product and batch information must be recorded in the patient file to guarantee the traceability of the product in the event of problems.
The MEB emphasises “the need for the treating physician and the (hospital) pharmacist to be involved in the decision to switch from one biosimilar medicinal product to another, so that an informed decision can be taken. Cooperation in the area of pharmacovigilance (efficacy and adverse events) is essential.”
The MEB also emphasises the importance of intercalating the use of - for example - the new generation of biosimilar therapeutic antibodies in registry studies and performing intensive monitoring and practice-based research.