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 ?
On the other hand, even if the Federal Circuit upholds the district court's decision, there is nothing in the Biosimilars Act that appears to prohibit a biosimilar applicant from bringing an administrative patent challenge before the Patent Trial and Appeal Board.
The biosimilar pathway allowed for a reduced cost ($75-250M) and reduced timelines (50-60%) when compared with developing a new molecule, creating a new market.
The report gives detailed insight on the various aspects related to the biosimilar market in India and its future growth opportunities in terms of domestic sales, biosimilar pipeline analysis, recently announced regulatory and approval process for development and marketing of biosimilars, partnerships for the development of biosimilar drugs and detailed information on expiry of patent drugs till 2015.
The general requirements for the licensing of biosimilars are outlined in the Act, which states that an application for a biosimilar product should contain information demonstrating that the biological product is biosimilar to a reference product based on the following:
Samsung Bioepis, the drug development arm of Samsung Group, has launched its Herceptin biosimilar in the UK through its marketing partner MSD, known as Merck & Co (NYSE: MRK) in the US and Canada, the Korea Herald reported on Friday.
Our credibility has been further endorsed by the recent USFDA approval of our Biosimilar Trastuzumab, which is also the first in the US.
Ogivri, an oncology medication, marks the first FDA-approved Herceptin biosimilar and the first biosimilar from the Mylan-Biocon partnership approved for use in the U.
The conference is organized by the Bulgarian Generic Pharmaceutical Association (BGFarm) and Medicines for Europe (European Association for Generic and Biosimilar Drugs).
The biosimilar product will be used for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers in India, Biocon said in a filing to the BSE.
There are currently three biosimilars on the market, including one product that is a biosimilar to filgrastim and two that are biosimilar to infliximab.
Some major challenges biosimilar manufacturers will face in processing and packaging are the variability of large-molecules and the necessity of providing FDA with sufficient evidence to prove clinical safety.
A biosimilar version of AbbVie Inc's blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc and Samsung Biologics, was approved by European Union regulators.