biologic

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  • adj

Synonyms for biologic

pertaining to biology or to life and living things

Synonyms

References in periodicals archive ?
Multinational generic companies that have already established themselves as biosimilar competitors in other regulated markets, such as Sandoz and Hospira, are also likely to be among the first to compete with follow-on biologic products in the US.
Unlike conventional drug products where generic competition is robust, the FDA lacks a clear regulatory pathway to approve follow-on biologics, or "biogenerics.
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The draft guidance is also expected to address the extent to which applications for follow-on biologics can reference studies conducted by the manufacturer of the source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.
What would a regulatory pathway for follow-on biologics really mean for the pharma sector?
CHICAGO -- Forty-four percent of industry executives believe the United States should follow the European approach for adopting follow-on biologics according to a survey of biotechnology executives conducted during BIO 2006.
However, the broader legal and public policy debate surrounding follow-on biologics has stymied the agency's efforts to set forth scientific guidelines.
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.
WASHINGTON -- The following statement was issued today by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood in conjunction with a hearing held this morning on follow-on biologics before the Senate Health, Education, Labor and Pensions Committee:
Against the backdrop of intensified pricing pressure brought about by the Medicare drug benefit, follow-on biologics are gaining more and more attention as the next frontier for generic companies.