The considerations take into account the unique characteristics of biologic medicines, which are capable of treating patients with highly complex diseases – and caution that switching stable patients is still nascent in practice. The three associations underscore the central role of the physician – together with the patient – in the decision-making process when it comes to providing the appropriate treatment for both naïve and disease-stable patients.
This means that:
- the prescribing physician must always retain the option to designate which biological product should be dispensed. Treatment decisions must be made first on the basis of clinical judgment and then on the overall value proposition offered by individual medicines; and
- the treating physician, in consultation with the patient, should make any decision to switch patients from one biological product to another. Where switching occurs, it must be accompanied by adequate clinical monitoring and the patient must be informed appropriately at all times.
All biologics approved by regulatory authorities (e.g. the European Medicines Agency) in compliance with relevant WHO guidelines are safe, effective and of high quality. Moreover, a biosimilar must be compared in terms of quality, safety and efficacy with its reference product before it qualifies for approval. However, there is no regulatory requirement for individually approved biosimilars for the same reference product to be compared with each other. Consequently, this type of data may not be available to stakeholders when evaluating a switch between two biosimilars of the same reference product.
The complex nature of biological molecules, which are often used to treat patients who have multifaceted, chronic diseases, means that any decision to switch should be made on a case‐by-case basis and must be patient-, disease- and product-specific. It is vital for a physician to balance the level of evidence against the level of risk or uncertainty in each particular case. A ‘one size fits all’ approach is not appropriate.
Biosimilars have an important role to play in promoting the sustainability of healthcare systems. Used appropriately, biosimilars will provide health systems with the financial headroom to maintain investment in new technologies and therapies. Our industry recognises its responsibility to support efforts that instill confidence in physicians and patients in the use of biosimilars, including through the promotion of appropriate clinical use and contributing to informed decision-making.
The position paper can be accessed here.
European Biopharmaceutical Enterprises (EBE) represents the voice of biopharmaceutical companies of all sizes in Europe and is a specialised group within the European Federation of Pharmaceutical Industries and Associations (EFPIA). Established in 2000, EBE is recognised as the leading biopharmaceutical association in Europe.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
IFPMA represents research-‐based pharmaceutical companies and associations across the globe.
The research‐based pharmaceutical industry’s 2 million employees research, develop and provide medicines and vaccines that improve the life of patients worldwide. Based in Geneva, IFPMA has official relations with the United Nations and contributes industry expertise to help the global health community find solutions that improve global health.
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