By European Generic Medicines Association
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Additional resources for Biosimilars Handbook
It is important to reiterate that biosimilar medicines match their reference product in terms of quality, efﬁcacy and safety. A demonstration of therapeutic equivalence is usually required in order to adopt the posology (dose recommendations) of the reference product8. The extensive comparability data, and also post-marketing data, will therefore demonstrate that it is safe and efﬁcacious to switch dose for dose from the reference product to the biosimilar medicine. Interchangeability refers to the medical practice of changing one medicine for another that is equivalent, in a given clinical setting on the initiative, or with the agreement of the prescriber.
This RMP must be agreed by the European Medicines Agency and is an integral part of the marketing authorisation. The RMP describes what is For adverse reaction (ADR) reports relating to all biopharmaceuticals, the deﬁnite identiﬁcation of the medicine with regard to its manufacturing is of particular importance. Therefore EU legislation requires that for every adverse reaction report of a biological medicine, the name of the medicine and the batch number must A summary of the data and the assessment about the medicinal product, known as a European public assessment report (EPAR) is made available to the public.
In addition, there are speciﬁc guidelines on biosimilar monoclonal antibodies being developed. BIOSIMILAR REGULATORY FRAMEWORKS OUTSIDE THE EU Due to its high quality, efﬁcacy and safety standards, the EU regulatory framework provides an excellent model for countries around the world. The EU legal framework offers the key advantage of separating any patent litigation from the regulatory approval processes. By doing so, it allows timely access to competitively-priced biosimilar medicines. This EU regulatory framework has already inspired many countries around the world and is continuing to do so.