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European Pharmaceutical Associations Urge Physicians to Exercise Caution When Prescribing Biosimilars

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The European Medicines Agency (EMA) has so-far approved 24 biosimilars of branded biologics.

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March 10, 2017 | by Sarah Hand, M.Sc.

Three pharmaceutical industry groups in the EU have published a document aimed at helping physicians decide when it’s medically appropriate to switch a patient from a biologic to a biosimilar. The paper – which was jointly composed by the European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) – comes at a time when biopharma companies are facing increasing competition from biosimilar drugmakers.

The associations explain that biologics are more complex than small molecule drugs, and their generic counterparts, that are often exchanged and substituted by physicians. This higher level of complexity demands that physicians retain their prescribing power, even in the face of government healthcare systems which could encourage them to switch patients to lower-cost biosimilar products.

“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,” said the document. “A ‘one size fits all’ approach is not appropriate.”

The authors also point out that currently, no regulatory requirements exist for individual biosimilars to be compared to each other in terms of similarity, safety and efficacy. Since these products are only required to be compared to the reference biologic, prescribing physicians will have little information available to help them determine whether switching a patient from one biosimilar to another, will be medically appropriate.

In the key considerations section of the report, the associations point out six key factors and considerations that they recommend physicians take into account when deciding whether a biologic prescription should be switched to a biosimilar. In addition, they outline two scenarios in which switching from a branded biologic to its biosimilar would not be recommended:

  1. When the initial treatments is not well-tolerated, or shows a loss in efficacy. As biosimilars must show similar safety and efficacy compared to their reference biologic in order to be granted regulatory approval, it’s unlikely that the patient would experience a clinical benefit as a results of switching between medicines.
  2. If the switch could potentially affect the future effectiveness of other biological therapies, physicians are not advised to do so. The immunogenicity consequences of multiple exposures to similar biological molecules is not well-characterized.

The European Medicines Agency (EMA) has so-far approved 24 biosimilars of branded biologics. In contrast, the US Food and Drug Administration (FDA) has approved just four biosimilars.

“The physician is best placed to assess the patient, disease and product, when deciding if and how to switch the biological product that a patient is receiving for another one,” said the authors. “Therefore, the physician should retain decision-making autonomy and have unrestricted choice of products to prescribe. When physicians are considering to switch treatment it is important that the patient history is taken into account and switches are recorded appropriately in the patient’s file, as well as the brand name and batch number of the products prescribed and dispensed.”


Keywords: Pharmaceutical, Biosimilar, EMA


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