Biosimilar medicines: access to clinical practice

12/7/2016

On 3rd November, the Health Research Foundation (Fundación para la Investigación en Salud – FUINSA) held a conference in Madrid to address the access of biosimilar medicines to clinical practice. Representatives from the leading medical societies took part in the conference with a view to outlining each one’s stance with regard to biosimilar drugs. The societies taking part were: the Spanish Rheumatology Society (SER); the Spanish Digestive Disease Society (SEPD); the Spanish Nephrology Society (S.E.N); the Spanish Hospital Pharmacy Society (SEFH); the National Arthritis Coordinator (ConArtritis); the Spanish Endocrinology and Nutrition Society (SEEN); the Spanish Medical Oncology Society (SEOM); the Spanish Haematology and Haemotherapy Society (SEHH); and the Spanish Neurology Society (SEN). Also participating was the Ministry of Health, Social Services and Equality.

 

The vast majority of the societies voiced their agreement with all the aspects we have mentioned in previous posts on biosimilars, such as their lower cost, the improved sustainability of healthcare systems, the promotion of research and greater availability of treatments for patients. One further important issue in which they also concurred is that of not considering biosimilars as generics of biological drugs. They stress that a generic drug cannot be compared with a biosimilar As such, the approach taken to decide on the price and funding of each one is not the same.

 

The differences existing between the substitution and interchangeability of drugs were explained: substitution is the replacement of a drug with a biosimilar by the pharmacy department, without taking into account the physician’s judgement or the patient’s approval, whereas interchangeability is the replacement of a drug with a biosimilar with the prescribing physician’s approval, and with the knowledge and approval of the patient. Owing to the characteristics of biosimilars, and as set out in the law, the societies do not consider these drugs to be substitutable. They explain that both substitution and interchangeability must be governed by a clear, well-defined legal framework, for which, in order to be able to perform said substitution or replacement, there is a need for greater scientific evidence in the extrapolation of indications. Even so, they consider that, of the two, interchangeability would be the ideal process.

 

Another aspect on which the societies agree is that of prescribing treatments by brand name and not by active substance, which would ensure the proper traceability and monitoring of any adverse events associated with the drug. In the event of traceability being lost, this would result in a lack of information on highly important aspects pertaining to the distribution of the drug, such as the batch number and the establishment to which the biosimilar being used belongs.

 

The conference concluded with a unanimous consensus on the importance of biosimilars, the development and marketing of which are not without unforeseen challenges, but which also offer opportunities that will allow progress to be made in the scientific and commercial settings.