The increase in the development, marketing and availability of biological therapies has revolutionized the treatment of certain chronic and serious diseases. In this respect, biosimilar medicinal products increase biological medicinal products’ therapeutic offer by reducing health care costs and improving patient access to this type of treatments. This cost-effectiveness improvement, in some cases, has triggered an average of 44% increase in the number of patients treated.1
For this reason, various scientific organisations have established their position on biosimilars since their commercialization in order to guarantee quality of care and patient safety.
The Spanish Society of Rheumatology (SER) is one among them. It has shown its commitment to the Spanish health system’s sustainability and aligned itself with measures to maintain this sustainability without reducing quality of care.
With this new scenario of an increase of the therapeutic offer of biologics, SER considers it essential to preserve doctors’ freedom to prescribe the medicinal products indicated according to each patient’s individual characteristics and the economic aspects. In the position paper on biosimilar medicinal products, SER recalls the importance of taking into account biosimilars are not generics since they are exact chemical copies of their reference medicinal product.
A biosimilar may be somewhat different due to the variability inherent to biological medicinal products, but these differences affect neither their efficacy nor their safety, which are equal to those of the reference medicinal product. For this reason, the society has insisted that switching a biologic reference product to its biosimilar must be a medical act, and believes that it should be performed exclusively by the prescribing physician with the patient’s consent.
Like reference medicinal products, biosimilars are subject to safety monitoring, and therefore specific pharmacovigilance records must be created. In terms of quality, and in order to specifically categorise suspected adverse events, traceability must be ensured through product and batch identification.
The optimal use of biosimilars requires constant dialogue and interaction between doctors, pharmacologists and regulatory authorities with the aim of preserving patients’ rights to health to provide them quality, effective and safe products.2
British Society of Rheumatology position statement on biosimilars medicines consider prescribing biosimilars should be made on a case by case basis, with the consent of the physician and based on clinical reasons and not solely as a measure to save money. Treatment options and any decisions on potential changes to medicines should be discussed in partnership with the patient, with full consent.3
American College of Rheumatology position statement highlight the approval process for biosimilars needs to place safety and efficacy, supported by scientifically evidence, establishing the need for more cost effective biologic therapies.4
At mAbxience, as a company focused on research, development and commercialization of biosimilar medicines, we are committed to deliver solutions and bring hope to as many people as possible by ensuring access to treatments and contributing to the sustainability of healthcare systems worldwide. More than 7,000 patients have been treated with our products; we are present in 100 countries through our partners and have launched our biosimilars in 7 different markets.
- Libro blanco de los medicamentos biosimilares en España: Innovación y sostenibilidad. Fundación Gaspar Casal. 2017
- Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares. Available at:https://www.ser.es/wp-content/uploads/2015/09/Posicionamiento-Biosimilares.pdf (last access January 12, 2008)
- British Society for Rheumatology Position statement on biosimilar medicines (Revised January 2017). Available at: https://www.nras.org.uk/data/files/revised_bsr_biosimilars_position_statement_jan_2017.pdf (last access January 12, 2018)
- American College of Rheumatology Position statement. Available at: https://www.rheumatology.org/portals/0/files/biosimilars-position-statement.pdf (last access January 12, 2018)