Although Celltrion and Pfizer’s Inflectra® was not approved as an interchangeable product to Remicade®, this will generally not matter to US payers when deciding the coverage of the product in patients who have not had anti-TNF treatment in the past. This is of even less importance to French prescribers, where the European Medicines Agency does not have a mandate to rule on the interchangeability of biosimilars. That means it’s entirely up to the health systems and physicians to decide this matter, including whether to allow substitution or switching.
The basic question is whether the evidence exists this biosimilar monoclonal antibody is close enough therapeutically to the innovator product to justify substitution. In a commentary, French physicians stated that substitution is a foregone conclusion in their country. There is a French law forbidding the practice of automatic therapeutic interchange, preventing systematic institution of the practice.
The biosimilar version of infliximab was approved in 2014, and as governments in the EU have generally not taken a stance on substitution, hospitals and other healthcare systems have addressed this issue, building a consensus based on the experience of the Assistance-Publique Hôpitaux de Paris (AP-HP) (this is the largest public hospital group in Europe, accounting for 22,000 beds and caring for 12 million patients). Unlike in the US, infliximab is administered in the hospital setting in France.
However, AP-HP does have its version of the typical US Pharmacy & Therapeutics Committee, called the Committee on Medicinal Products (COMED). This hospital system decided that COMED should decide for itself whether infliximab biosimilars yielded essentially equivalent outcomes and on substitution issues within its hospitals. Last year, it came to the conclusion that the two available biosimilars were substitutable for each other and the originator product.
Furthermore, COMED recommended that (1) “a vigorous post-approval surveillance (full traceability) of these products should be implemented in AP-HP” and (2) “physicians should be encouraged to take part in the registries that will be implemented by the medical disciplines concerned in the AP-HP.”
Back in the US, will payers make their own public statements on switching? This is unlikely, owing to the potential for negative press, but it could ease any concerns prescribers have in using biosimilars. Again, the choice of prescription, without an interchangeability designation, is still in the doctor’s hands. It will be largely up to them to speed adoption.