Similar biological medicinal products - definition of similar biological medicinal products by The Free Dictionary
biosimilar (redirected from similar biological medicinal products)
Also found in: Medical
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.
A biological product that is biosimilar to an existing product, especially to a biologic.
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References in periodicals archive
Guideline on similar biological medicinal products
containing biotechnology-derived proteins as active substance: non-clinical and clinical issues.
(32) EMA Procedural advice for users of Centralised Procedure for Similar Biological Medicinal Products
applications, European Medicines Agency (Oct.
Guideline on Similar Biological Medicinal Products
, CHMP/437/04 Rev 1, 2014.
(5.) Guideline on similar biological medicinal products
containing monoclonal antibodies (Draft), 18 November 2010, EMA/CHMP/ BMWP/403543/2010, European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP).
New provisions on generics and similar biological medicinal products
also call for the definition of related fees.