EMA (European Medicines Agency)
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product) in the European Economic Area (EEA).
Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established.1
FDA (Food and Drug Administration – US)
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.2
BioSim (Spanish Biosimilar Medicines Association)
A biosimilar medicine (or similar biological medicine) is a biological medicine that contains a version of the active substance of an original biological product (reference product) for which equivalence has been demonstrated. The biosimilar medicine is approved for all, or some of the indications of the reference product, and its posology and route of administration must be the same. Equivalence with the reference product must be established by means of an exhaustive “comparability exercise”.
The object of this exercise is to demonstrate that the slight physicochemical differences that exist between the two products have no significant impact on the quality, efficacy and safety of the biosimilar, implying that the active substance of both medicinal products is essentially the same.3
At mAbxience we maximize our in-depth pharmaceutical knowledge and experience to meet the objective of developing and offering innovative therapeutic solutions, with the highest quality, covering a wide range of diseases and giving access to as many people as possible.
For this reason, mAbxience focus its resources and efforts on R&D activities, which are developed through its network of centers of excellence, located in various countries of the European Union and Latin America.
mAbxience works under ICH Q10 framework and cGxP regulations for all of our biosimilar products development.
CHO: Chinese Hamster Ovary
QTPP: Quality Target Product Profile
RMP: Reference Medicinal Product
QbD: Quality by Design
ICH: International Conference on Harmonization
cGxP: Current Good X Practice (X can mean: Clinical, Laboratory, Manufacturing, Pharmaceutical)
The research and development of our products are carried out in our manufacturing plants in León (Spain), acquired in 2014 and inaugurated in October 2015, and in Buenos Aires (Argentina), acquired in 2010 and inaugurated in June of 2012.
- European Medicines Agency: Guideline on similar biological medicinal products. EMEA/CHMP/437/04 Rev. 1. Available on: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf.
- Food and Drug Administration: Information on Biosimilars. Available on: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/.
- BioSim. The biosimilar medicines decalogue. Available on. Available: http://www.biosim.es/documentos/the-biosimilar-medicines-decalogue.pdf.