Building a consensus, however, on substitution practices among physicians, pharmacists and administrative departments in health facilities appears to be very difficult. The recent experience of the Assistance-Publique Hôpitaux de Paris (AP-HP) – the largest public hospital group in Europe with 22,000 beds and caring for 12 million patients annually – in this field shows that it is, however, possible.

The Committee on Medicinal Products (COMED) of AP-HP is in charge of listing the medicines on the hospital drug formulary or making a decision on whether drugs and therapeutic equivalents should enter into a competition. COMED recently met the challenge of assessing the infliximab biosimilars marketed in the EU from a medical point of view and had to position itself on the interchangeability and substitution issues of biosimilars within the hospitals of the AP-HP. In 2015, COMED of AP-HP decided that infliximab biosimilars and their originator (Remicade, corresponding to a 42-million-Euro expense per year for AP-HP) could be considered as therapeutically equivalent and, thus, could be authorized to participate in the same tender.

In reaching this conclusion, COMED followed a rigorous decision-making process made up of several steps and which included the following:
• assessment of the therapeutic equivalence between the two infliximab biosimilars and the originator (without switches and with switches in ankylosing spondylitis and rheumatoid arthritis)
• evaluation of the risk management plan for the infliximab biosimilars compared to Remicade
• assessment of the immunogenicity data of the biosimilars provided by laboratories (observational studies in ankylosing spondylitis, rheumatoid arthritis and Crohn’s disease without switches and with switches)
• budget impact analysis of listing one or several infliximab products (biosimilars or not) on the hospital drug formulary.

In addition to its decision, COMED made two recommendations. First that a vigorous post-approval surveillance (full traceability) of these products should be implemented in the AP-HP following the tender. Second, that physicians should be encouraged to take part in the registries that will be implemented by the medical disciplines concerned in the AP-HP.

The tender related to infliximab products in the AP-HP was actually only implemented for naïve patients, as the current French law does not allow switching from brand-name biologicals to biosimilars for ‘pretreated’ patients. In 2015, an infliximab biosimilar finally won the tender that resulted in an estimated 45% discount of the price, equivalent to an estimated Euros 6 million gain per year for the AP-HP. On top of that, the re-negotiation of the brand-name infliximab price generated more than Euros 1 million in savings for the institution.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Dr François Bocquet of the AP-HP and the Faculty of Pharmacy, Paris Descartes University, Sorbonne, Paris, France.

Related articles
Switching between different ESAs

Biosimilars and interchangeability

Reference
1. Bocquet F, Paubel P. First monoclonal antibody biosimilars: tackling the challenge of substitution. J Med Econ. 2016;19(6):645-7.

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