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 ?
Despite strong concerns from more than 75 patients, healthcare providers, stakeholder organizations, and twenty additional Senators, CMS finalized the Medicare reimbursement of biosimilars policy, placing all biosimilar products under the same billing and payment code.
Additional data from the study showed that there were no clinically meaningful differences between the proposed biosimilar pegfilgrastim and the reference product.
The biosimilar applications in blood disorders and oncology collectively evaluated at 61% in 2014 - Interferon is fastest growing biosimilar, expected to grow at a CAGR of 51.
The report assesses the degree to which CMOs that manufacture drug-substance or drug-product might benefit from the biosimilar boom.
In February, the agency issued a draft guidance on biosimilar product development.
Clinical experience with infliximab biosimilar - switch from Remicade.
The highly awaited US Biosimilar market will be initiated in September as Sandoz launches its highly awaited filigrastim biologic, Zarxio.
One point of clarity that has emerged is that dynamics of the biosimilar market are unlike those associated with the small molecule generics market.
Under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), the application was registered.
BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that surveyed gastroenterologists and rheumatologists in the United States and Europe have a low or medium-low likelihood of prescribing a biosimilar for an indication in which it has not been clinically tested.