biosimilar

(redirected from Biosimilars)
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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 ?
M2 EQUITYBITES-March 9, 2018-Samsung Bioepis launches first Herceptin biosimilar in Europe
This synergistic partnership will enable us to scale up our capabilities for an end to end play in the global biosimilars space.
The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.
Biotechnology major Biocon said it has launched its cancer biosimilar drug KRABEVA in India.
Given the level of uncertainty surrounding the biosimilars market, however, the range of savings could be as low at $24 billion or as high as $150 billion.
Patrick will be presenting an exclusive session at the conference on where the market for biosimilars is heading, including key milestones and challenges overcome.
Pharmaceutical manufacturers must prepare themselves for some of the challenges that lie ahead for the biosimilars market.
Netscribes latest market research report titled Biosimilars Market in India 2017, describes the current and forecasted dynamics of the biosimilars market in India.
Netscribes' latest market research report titled Biosimilars Market in India 2017, describes the current and forecasted dynamics of the biosimilars market in India.
In terms of data required for marketing authorization, biologics and biosimilars have different requirements.
Other drug companies - whether it is Biocon, Mylan, Reliance Life Sciences and, now, Hetero - have, for over two years now, been battling legal challenges to their biosimilars from innovator companies such as Roche.
The lack of an abbreviated pathway means that manufacturers of biosimilars had to go through the same lengthy and costly FDA process as developers of brand-name biologics, or innovators, to obtain approval for their product.