biosimilar

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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.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.

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.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.

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
Medical Dictionary, © 2009 Farlex and Partners
References in periodicals archive ?
Public bioassay data is inherently sparse, and therefore, calculating biosimilarity alone can offer misleading results due to missing data.
The Pelmeg confirmed biosimilarity to Neulasta in sensitive clinical study settings, demonstrated pharmacokinetic comparability to Neulasta at the clinical dose of 6 mg as well as pharmacodynamic comparability to Neulasta at the clinical dose of 6 mg and at the reduced dose of 3 mg, added the network.
[5] Datos tomados de la List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date actualizada el 13 de diciembre de 2017 en el Purple Book que se refiere a la lista de medicamentos biologicos, incluyendo los biosimilares, aprobados por el Center for Drug Evaluation and Research (cder).
For the biosimilarity pathway, extensive preclinical documentation on the biosimilar characteristics in comparison to the reference product is provided, and the biosimilar must crucially demonstrate similarity to the reference product in terms of safety and efficacy based on clinical data.
[13] US Food and Drug Administration and Center for Drug Evaluation and Research, List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date, 2016.
The resources provide basics such as the basic definition associated with biosimilars (i.e., what is a biosimilar and a reference product, and what it means to be interchangeable), the standards of approval that biosimilars must go through, and easily accessible information on what the FDA is using to review biosimilarity.
Interchangeability is a regulatory designation that is different from that of biosimilarity. Though the FDA has not issued specific guidance on interchangeability, it has proposed that the sponsor of a follow-on biologic would need to demonstrate, in either pre- or postmarketing studies, that repeated switches from the follow-on biologic to its reference product would show no negative effects with respect to safety, efficacy, or immunogenicity.
bioequivalence, but merely biosimilarity, to a reference product.
To demonstrate the biosimilarity, the state-of-the-art robust methodologies (Table 1) including chromatographic, electrophoretic, and cell-based bioassay methods, along with CD, DSC, MS, and SPR technologies, were employed to compare biosimilar tocilizumab HS628 and originator tocilizumab.
According to the FDA, biosimilars are a type of biological product that are "highly similar to an already FDA-approved biological product." An interchangeable biological product, on the other hand, "in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient."
In addition to the general guidelines on biosimilarity, the EMA also provides product-specific guidelines that address different types of biosimilars.
Quality Considerations in Demonstrating Biosimilarity to a Reference Product, 2012.