biologic

(redirected from Follow-on Biologic)
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Synonyms for biologic

pertaining to biology or to life and living things

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References in periodicals archive ?
WASHINGTON -- The Federal Trade Commission will hold a daylong public workshop on issues relating to follow-on biologics February 4 at the FTC's conference center here.
Baxter's global footprint and extensive development, manufacturing and commercial expertise are exactly what we need to succeed in building a leading follow-on biologics business.
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.
Reportlinker Adds Biosimilars and Follow-On Biologics Report: The Global Outlook 2009-2024
Insmed's pipeline of follow-on biologic candidates presents the opportunity to expedite Merck's entry into the biologics marketplace as well as providing unique manufacturing resources and an experienced team of protein experts," said Frank K.
The FDA is planning to release a draft guidance on follow-on biologics this spring.
Food and Drug Administration (FDA) to review and approve follow-on biologic drugs.
WASHINGTON -- As the House of Representatives' Committee on Energy and Commerce holds a hearing today on follow-on biologics, the Biotechnology Industry Organization (BIO) issued a statement of facts in response to misleading public statements on follow-on biologics made by the Generic Pharmaceutical Association (GPhA) and others.
Burlington will discuss the commercial implications of follow-on biologics from an innovator perspective.
Top Names in Follow-on Biologics to Share Their Insights
Set against the backdrop of the looming FDA review of Omnitrope, 70 percent of respondents who characterized themselves as "researchers" believe the current state of science allows companies to establish pharmaceutical equivalence and bio equivalence of follow-on biologic products, two requirements for FDA approval.
However, even if legislation enabling a follow-on biologics pathway had passed, it would take several years before practicing physicians had the opportunity to prescribe the generics, noted Dr.
The Omnitrope NDA is seen as a "test case" at the agency for approval of follow-on biologics under the 505(b)(2) pathway.
WASHINGTON -- The Biotechnology Industry Organization (BIO) released today a white paper entitled, "The Difference with Biologics: The Scientific, Legal and Regulatory Challenges of Any Follow-On Biologics Scheme.
Any Statutory Pathway for the Approval of Follow-On Biologics Must Protect Patient Safety and Preserve Incentives to Innovate