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.

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 ?
At each step," the regulation says, "the sponsor should evaluate the extent to which there is residual uncertainty about the biosimilarity of the proposed product and identify next steps to try to address that uncertainty.
Yet, because of the subtle distinction between bioequivalence and biosimilarity, Hatch-Waxman increased generic competition in the market for traditional drugs while failing to similarly encourage follow-on biologics development and distribution.
Legal strategies seeking to defend or invalidate intellectual property, and question biosimilarity claims, gather momentum 3.
Both studies are consistent with the assessment of biosimilarity between the reference product, EPOGEN, and the Hospira proposed biosimilar, Epoetin Hospira," said Stan Bukofzer, M.
The more large and complex a molecule is, the more difficult it will be to convince regulatory authorities of biosimilarity ".
In a phase 3 (randomized, double-blind) study in rheumatoid arthritis patients, INFLECTRA met its primary endpoint of biosimilarity to REMICADE.
The standard for finding biosimilarity is weakened significantly in the bill because the information required to be submitted by the follow-on applicant can be waived by the FDA, and it is not clear from the language of the bill that critical requirements from the application - such as animal studies, assessment of immunogenicity, pharmacokinetics or pharmacodynamics, and standards for the manufacturing facility, among others - are required to be incorporated in the approval determination.
biosimilar approved, Zarxio(TM) (filgrastim-sndz), has the identical data package to its reference product and does not include statements of biosimilarity or interchangeability.
This challenge is now showing signs of easing, particularly in Western Europe where the European Agency for the Evaluation of Medicinal Products (EMEA) is now accepting Market Authorisation Applications (MAA's) for biogeneric products, which show proven biosimilarity in place of clinical trials.
Sections on pharmacovigilance and issues surrounding biosimilarity
These approvals are based primarily on showing biosimilarity or lack of significant differences in structure, activity and clinical efficacy and safety compared to an already-approved "reference" product.