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Position of Paul-Ehrlich-Institut regarding the use of biosimilars

The term biosimilar refers to a biological medicinal product which contains a version of the active ingredient of a biological medicinal product (known as reference product or originator product) already authorised in the EU.

As part of the marketing authorisation procedure, in which the risk/benefit balance of a product is assessed, the Committee for Medicinal Products for Human Use (CHMP) primarily evaluates the direct comparison of the pharmaceutical quality, efficacy, and safety of a product for which a marketing authorization application has been submitted and not its interchangeability.

According to the current status of the discussion at the CHMP and its working parties, biosimilars can in principle be used in the same way as originator products after equivalence has been proven and the marketing authorisation has been granted. This implies that they can be administered to both, patients who have not previously been treated with biologics and those who previously have received the originator product. The Paul-Ehrlich-Institut holds the view that any treatment decision of the physician must be based on scientific data, especially with regard to proven high-grade comparability of a biosimilar to its originator product and the scientific plausibility of all data included in the discussion.

The extent to which a physician is consulted before a decision is taken on which of the medicinal products with comparable therapeutic risk/benefit ratio shall be administered (originator product or biosimilar) – in other words, whether or not a product is automatically substituted – is not within the competence of the national or European regulatory authority but rather depends on the respective national health care systems.

Since September 2013, when the first biosimilar products (Inflectra and Remsima) of a monoclonal antibody (Remicade) were granted a marketing authorisationmore than 20 Biosimilars of this product class have been approved for the treatment of autoimmune and cancer diseases and are largely available on the German market (EMA Website). So far, the Paul-Ehrlich-Institut has not received any report that switching from anyreference product to a biosimilar product has led to problems in the treatment of patients. An increasing number of publications in the scientific literature can be found on biosimilars indicating that no safety problems occur when switching from an originator product to a biosimilar.

The treating physician should at any rate ascertain that any adverse effects that may occur during treatment withBiosimilar monoclonal antibodies , and even the original product, be reported adequately within the pharmacovigilance system, so that they can be followed up. The current pharmacovigilance guideline (Guideline on good pharmacovigilance practice, Module VI Risk management systems, EMA/873138/2011 Rev 1*) states that the Identification of a biological medicinal product in a pharmacovigilance report requires the relevant brand name and the batch number in addition to the active substance.

If a prescription only shows the nonproprietary name of the active substance, the pharmacist or physician must assure compliance with the pharmacovigilance guideline by documenting product name and batch number before dispension (in case of s.c. application) or administration (in case of i.v. application ) of the product to the patient. ensure that the pharmacovigilance guideline is observed.

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