Farmaindustria defends the non-interchangeability principle for biologic and biosimilar medicines

Speaking at the first Biological Medicines Forum organized by the Associations last week, the president of trade group Farmaindustria, Antoni Esteve, defended the principle of non-interchangeability of biological and biosimilar medicines. “Only an individualized deliberation might advise to change a treatment which is already working well for a given patient,” he said.

He insisted that the R&D-based pharmaceutical industry shares the objective with health care authorities of attaining savings which stem from the loss of exclusivity of biological products. However, he stressed that these savings are reached by the basic principles of non-substitution, and once the patent protection has expired, and out of respect for maximum competition, any kind of discrimination of original products is to be avoided.

Mr Esteve, who was joined in the inauguration by the Spanish General Secretary of Science, Technology and Innovation, María Luisa Poncela, assured that in spite of it being very difficult to produce medicines, “the R&D based pharmaceutical industry will keep on evolving to satisfy the increasing demand of these new medicines.” During the last decade, biologic medicines have accounted for a third of approvals of new medicines, in spite of the great uncertainty and growing costs associated to the research of this kind of medicines. For all these reasons, he stated the importance fostering a framework of greater regulatory certainty, so to impulse their research.