Madrid, March 13^th 2015.– The President of Farmaindustria, Antoni Esteve, defended this morning, during the first Biological Medicines Forum organized by the Associations he presides, the principle of not 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 remarked.

He insisted that the R&D based pharmaceutical industry shares the objective with healthcare 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.

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.

Biological medicines are structurally different to traditional chemical synthesis ones and allow, in many cases, to develop a more accurate and efficient approach to the disease. In certain pathologies, this kind of medicine has already become the very first available treatment. In this regard, Farmaindustria’s President pointed out that “not only do they stand for an expression of progress against certain kind of pathologies, but they also bring hope for tackling many other diseases”:

Currently, almost a thousand medicines and vaccines of biological origin are already in ongoing research and development processes, and it is expected that in 2016,  more  biological medicines will be sold than any other types, with their global market reaching 18 thousand million dollars in 2017.

Farmaindustria’s  President went on to say that in this sense, the upsurge of biological medicines represents a true therapeutic and economic revolution, but also an important challenge -both for healthcare authorities and for the pharmaceutical industry-  as far as regulation and pharmaceutical policies are concerned, therefore insisting that it is necessary to reduce the uncertainty which surrounds the regulatory environment and reimbursement policies to avoid the retraction on investments and reinforcing the industrial property policies.

“By collaborating with each other, we must be capable of designing a clear and transparent path to determine the future of biological medicines in Spain, which is something which industry, patients and society in general are placing a high bet on”, he concluded.

Regulatory, scientific and economic challenges

This first Forum consisted of two round tables and the most important challenges tied to these medicines were tackled. Namely, in the first session, regulatory challenges were discussed with the interventions of Belén Crespo, Director of the Spanish Medicines and Healthcare Products Agency (AEMPS); Richard Bergström, Director General of EFPIA; Sol Ruiz, Chair of the Biologics Working Party (EMA); Fermín Ruiz de Ernechun, Chair of the IFPMA Biotherapeutics Group and Humberto Arnés, Director General of Farmaindustria, who was the moderator.

On the other hand, the second session on scientific and economic challenges counted on the participation of Agustín Rivero, Director General of Pharmacy of the Ministry of Health, Social Services and Equality; Fernando Rivera, member of the Executive Committee of the Spanish Oncology Society; Fernando Carballo, President of the Spanish Society of Digestive Pathologies; Álvaro Hidalgo, Professor of Economic Analysis Fundamentals of the University of Castilla-La Mancha; Daniel Aníbal García, Secretary General of the Spanish Federation of  Haemophilia (Fedhemo); and Ángel Fernández, President of  Merck, Sharp & Dohme Spain was the moderator.