The manual, which has been presented at the headquarters of the Collegiate Medical Organization, contains basic information on these drugs aimed at medical training.
Madrid, July 4 of 2017. The Spanish Association of Biosimilars has prepared a Guide on these drugs that has been presented on the morning of July 4, at the headquarters of the Collegiate Medical Organization.
The presentation has had the participation of Javier Castrodeza, Secretary General of the Ministry of Health, Social Services and Equality; Dr. Serafín Romero, President of the WTO; Joaquín Rodrigo, president of the Spanish Association of Biosimilars (BioSim), and Dr. Pedro Hidalgo, president of the Autonomous Council of Medical Colleges of Extremadura and Coordinator of the OMC Prescription Observatory.
The author of the Guide, Dr. Gonzalo Calvo, head of the Clinical Pharmacology Service of the Hospital Clinic of Barcelona, with several years of experience in the European Medicines Agency (EMA) and in the European Association of Clinical Pharmacology and Therapeutics (EACPT). ), has exposed its content and the objective pursued by the Spanish Association of Biosimilars, an organization that represents 17 companies that research, develop, manufacture and market these medicines.
The main objective of this guide is to inform and train doctors and healthcare professionals about these medicines. It offers detailed information on what biological medicines and biosilimars are; which of the latter are currently authorized in Europe; information on the guarantees of quality, efficacy and safety, both clinical and legal, compared to reference or biological medicines; the clinical interchangeability criteria that can be used; and finally a glossary related to these medications.
The Guide also shows the difference between a biosimilar medicine and a generic one; It includes the scientific foundation that supports the approval of biosimilars and how this process is carried out, as well as the recommendations and clarifications for doctors when starting a treatment with a biological medicine.
According to the European Medicines Agency (EMA) and as described in the Guide, a biosimilar is a biological medicine that contains a version of the active principle of an original biological product or reference product, whose patent has expired, against which it demonstrates that the Slight physicochemical and biological differences do not affect quality, efficacy and safety.
Biosimilar medicines are prescribed and dispensed mainly in the hospital setting, but also in the Primary Care setting, and this market is at a moment of momentum and development, especially with the arrival of new oncology biosimilars.
As is well known, today there are already 29 biosimilar medicines authorized in Europe, for twelve different original biologics. And it is expected that the number will continue to grow, to the extent that the range of molecules that can be developed under the biosimilar concept expands. Europe is a privileged health space, where the largest number of authorized biosimilars in the world is currently registered, under the demanding conditions of efficacy and safety endorsed by the European Medicines Agency.