Spain’s Position on Biosimilars

The associations EBE, EFPIA and IFPMA last week presented a position paper on the prescription of biosimilar drugs. The paper, entitled “Considerations for Physicians on Biosimilar Switching Decisions,” explains the requirements that clinicians must consider when modifying a patient’s treatment. With the introduction of biosimilars, physicians can consider their use in various diseases treated with biological, for example to save costs.

If the clinician decides to change the treatment, he / she must perform an adequate clinical control and inform the patient. In this sense, they explain that the biological products approved by the regulatory authorities are safe, effective and of high quality. However, there are no regulatory requirements for individually approved biosimilars for the same reference product to be compared. Any change decision should be studied on a case-by-case basis depending on the patient, disease and product.

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Published 14. March 2017 in News Spain