Biosimilars Handbook by European Generic Medicines Association

By European Generic Medicines Association

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This guideline is available for adoption, either as a whole or partially, by national medicines regulators around the world or used as the basis for establishing national regulatory frameworks. Establishing a worldwide framework for biosimilar medicines is expected to contribute enormously to public health and patients’ access to medicines. The basic scientific principles underlying the WHO guideline are the same as those in the EU guidelines. com/ D Gedeon Richter Plc. hu/EN D Hospira Inc. com/ D Mylan Inc.

Hu/EN D Hospira Inc. com/ D Mylan Inc. V. com/ Chair of the Handbook Editorial Board: Dr. ) EGA-EBG Handbook Editorial Board Company Representatives: Dr. ), Dr. ), Dr. Erich Kohler (BioGenerix AG), Dr. Dieter Moecke (STADA Arzneimittel AG), Dr. ), and Ingrid Schwarzenberger (Sandoz GmbH). EGA-EBG Contributor and Coordinator: Suzette Kox, Senior Director Scientific Affairs EGA, Brussels, Belgium DISCLAIMER The information in this handbook contains the views of the EGA-EBG member companies listed above, and is not to be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or any other regulatory agency, or one of its committees or working parties.

The ability to substitute) refers to the pharmaceutical practice of dispensing one medicine instead of another equivalent and interchangeable medicine at pharmacy level and without requiring consultation with the prescriber. The term ‘automatic substitution’ refers to the practice whereby the pharmacist is obliged to dispense one medicine for another equivalent and interchangeable medicine due to national or local requirements. Substitution is governed by national laws, which vary from country to country and which may take both scientific and other factors into account.

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