Global trade bodies issue guidance on biosimilar switching

The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between original reference biologics and biosimilars.

In their position paper, ‘Considerations for physicians on switching decisions regarding biosimilars’, the associations recommend that:

• Prescribing physicians must always retain the option to designate which biological product should be dispensed, and treatment decisions must be made first on the basis of clinical judgment and then on the overall value proposition of individual medicines
• Treating physicians, in consultation with patients, should make any decision to switch patients between biological products, and switching must be accompanied by adequate clinical monitoring with the patient kept appropriately informed at all times.

The position paper stresses that, due to the complex nature of biological molecules, any decision to switch should be made on a case-by-case basis and must be patient-­, disease- and product-specific. It also urges physicians to balance the level of evidence against the level of risk or uncertainty in each case.

“A ‘one size fits all’ approach is not appropriate,” it says.