biosimilar

(redirected from similar biological medicinal products)
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biosimilar

(bī′ō-sĭm′ə-lər)
adj.
Highly similar in function and effect to an existing biological product, especially to a biologic that has already been clinically tested and approved for use.
n.
A biological product that is biosimilar to an existing product, especially to a biologic.

biosimilar

adjective Referring to a biosimilar therapeutics agent.
 
noun A biopharmaceutical which is produced by a different manufacturer after the expiration of the patent and marketing exclusivity of an original innovative biological product (e.g., a therapeutic monoclonal antibody).
 
In contrast to small (non-biological) agents, for which manufacturing an equivalent product is a relatively straightforward chemical process, biosimilars are not produced from the original clones and cell lines used to produce the tested and proven-effective agent; they thus may have therapeutic and metabolic profiles that differ from the clinically tested and proven products.

biosimilar

(bi?o-sim'i-lar) [ bio- + similar]
1. A generic version of a biologically active pharmaceutical agent, e.g., of a manufactured antibody or hormone.
2. Pert. to such a generic version.
Synonym: follow-on biologicbiosimilarity
References in periodicals archive ?
34) Guideline on similar biological medicinal products containing monoclonal antibodies--non-clinical and clinical issues, European Medicines Agency (May 30, 2012), http://www.
36) Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight-Heparins, European Medicines Agency (Mar.
Finally, a specific fee has been defined for similar biological medicinal products, based on the complex nature of these medicines.
On 26 November 2010, the EMA released related draft guidelines, the first on similar biological medicinal products containing monoclonal antibodies (mAbs) and the second on immunogenicity assessment of mAbs intended for in vivo clinical use.
More importantly, based on experience gained from the smaller protein molecules already assessed, a guideline on the "Development of Similar Biological Medicinal Products containing Monoclonal Antibodies" (10) has been published by EMA.
CHMP/437/04 Guideline on Similar Biological Medicinal Products.
19) The Guideline on Similar Biological Medicinal Products introduces the basic principles of the 'similar biological medicinal product' approach.