Spain to reduce the prices of new biosimilars by up to 30%

After months of uncertainty, the Spanish Ministry of Health has announced its new policy for the biosimilars of monoclonal antibody (MAb) drugs. The decision was made in October, in a meeting of the Comisión Interministerial de Precios de los Medicamentos (CIPM), the main authority in the pricing and reimbursement process, which had to decide about the inclusion of infliximab biosimilars in the National Health System, reports The Pharma Letter’s Spain correspondent.

“In that session, we established the reference’s criteria for applying the maximum industrial price (PVL) for the new biosimilar drugs which are going to be reimbursed in the National Health System (SNS), taking into account that the majority of them will be monoclonal antibodies. Specifically, the price of these products will be calculated with a discount of 25%-30% over the original drug’s PVL,” people from the Ministry said, adding that these criteria “will be applied with enough flexibility to maintain the sustainability of SNS.”

This new paradigm was applied in the case of infliximab biosimilars (Remsima, which has been developed by South Korean biotech firm Celltrion and will be sold by Spain’s Kern Pharma; and Inflectra, developed and commercialized by Hospira in Spain). The chief executive officer of Kern Pharma, Raúl Díaz-Varela, confirmed that the Remsima’s price "is 25% lower than the original, and that it has been established at 402 euros.” Despite this, the company “will now have to negotiate with each regional government and hospital, so the final discount will be near to 30%,” he added.