Glossary

  • Active substance: Active ingredient or molecule which provides a specific medicine with properties for treating or preventing one or several specific disease(s).
  • Biopharmaceuticals / biotechnology-derived medicines: A medicine or a vaccine that consists of, or has been produced by the use of living organisms. Often recombinant DNA (a form of DNA that does not exist naturally and which combines DNA sequences that would not normally occur together in order to establish new functions) forms the basis for biotechnologically manufactured medicines. Examples include therapeutic proteins such as antibodies, insulins or interleukins; but also vaccines, nucleic acid or tissues and cells.
  • Biosimilar medicine: A biological medicine that is developed to be similar to an existing biological medicine (the ‘reference medicine’). Biosimilar medicines can only be marketed following the patent expiry of the reference medicine (also called originator medicines).
  • Biotechnology: Any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use. An example is the reproduction of human hormones like insulin.
  • Cell line [including master cell line]: A well-established, living system of cultured (grown in a laboratory) cells that will continue to grow and produce new cells indefinitely, so long as the cells receive nourishment and have space to develop.
  • Extrapolation of indications: Extrapolation is the scientific and regulatory process of granting a clinical indication to a medicine without conducting a clinical efficacy and safety study to support that indication
  • Generic medicine: A medicine that is developed to match a medicine that has already been authorised (the ‘reference medicine‘). According to Directive 2001/83/EC ‘generic medicinal product’ is a medicine which matches the qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicine, and whose bioequivalence with the reference medicine has been demonstrated by appropriate bioavailability studies. A generic medicine can only be marketed after the loss of market exclusivity of the reference medicine (also called ‘originator medicine).
  • Glycosylation: The type and length of any sugar or carbohydrate groups that are attached to a given molecule, such as a protein.
  • Immunogenicity: The potential or ability of a substance or antigen to cause an immune reaction/response.
  • INN: International Non-proprietary Name which identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property. A non-proprietary name is also known as a generic name.
  • Interchangeability: The medical practice of changing one medicine for another that is expected to match the clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of the prescriber.
  • Marketing authorisation: The permission granted by a regulatory authority to a company to market a medicine in accordance with the indications described in the product information, following the company's submission of required documentation and data in line with the regulatory and legal framework.
  • Pharmacovigilance: Science and safety control procedures to which medicines are subject before, during and after their approval by regulatory authorities with the aim of detecting, assessing and understanding the benefit: risk profile of a medicine. Pharmacovigilance activities cover the whole life-cycle management of medicines in relation to safety.
  • Reference product (medicine): A medicine which has been granted a marketing authorisation by a Member State or by the European Commission on the basis of submitted quality, preclinical and clinical data, to which the application for marketing authorisation for a generic or a biosimilar medicine refers.
  • Risk management plan: A detailed description of the risk management system implemented by the manufacturer for a given medicine.
  • Risk management system: Set of pharmacovigilance activities and interventions which are designed to identify, characterise, prevent or minimise risks relating to a medicine, including assessment of the benefit: risk profile of a given medicine.
  • Substitution: Practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without consulting the prescriber.
  • Switching: Decision by the treating physician to exchange one medicine for another medicine, matching the therapeutic intent in patients who are undergoing treatment.

 

Homepage

Homepage

The Biosimilars in Oncology Knowledge Centre provides healthcare professionals with up-to-date medical information and resources to improve their understanding of biosimilars.

Resources

Resources

A number of useful resources are provided here, such as useful links to relevant societies and organisations.

Upcoming Events

Upcoming Events

Explore our list of upcoming events that are relevant to biological medicines and biosimilars, containing information on key conferences, congresses and meetings.


 

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