biosimilar

(redirected from Follow-on Biologics)
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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 ?
Also, it is unclear whether existing models have fully taken into account the potential incentives for follow-on biologic players in the US to file biologics licence applications (BLAs) rather than abbreviated biologics licence applications (aBLAs).
Whereas established business strategies that have shaped the generics industry in the US such as paragraph IV patent challenges will not be part of the biosimilars market, new unique trends, including significant involvement from Big Pharma, are already emerging in US follow-on biologic competition.
Unlike conventional drug products where generic competition is robust, the FDA lacks a clear regulatory pathway to approve follow-on biologics, or "biogenerics.
During that time, the agency has worked to sort out scientific issues relating to follow-on biologics, and a historical white paper and guidance documents on the subject are under development.
The scientific, legal and regulatory issues involved in creating any approval pathway for follow-on biologics are complicated," stated Jim Greenwood, president and CEO of BIO.
Until FDA develops a clear stance on each of these complicated issues, follow-on biologics in the US will remain static and unresolved," says Eric Bolesh, lead author of "Combating Generics: Pharmaceutical Brand Defense for 2007" (http://www.
The draft guidance is also expected to address the extent to which applications for follow-on biologics can reference studies conducted by the manufacturer of the source biologic.
BIO opposes the follow-on biologics legislation proposed by Senators Hillary Clinton (D-NY) and Charles Schumer (D-NY) - as well as similar legislation introduced in the House of Representatives by Congressman Henry Waxman (D-CA).
There may be no bigger commercial issue for the biopharmaceutical sector than the question of whether and how the Food & Drug Administration (FDA) will allow an abbreviated shortcut to market for follow-on biologic products.
What would a regulatory pathway for follow-on biologics really mean for the pharma sector?
How lawmakers, regulators and industry leaders view the policy and legal implications of follow-on biologics