Generic Drugs/Biosimilars

Oct 29, 2015
By Pharmaceutical Technology Editors
USP responds to FDA's draft guidance on the naming of biological products.
Oct 27, 2015
Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.
Oct 08, 2015
Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.
Sep 28, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency releases guidance on controlled correspondences related to generic-drug development.
Sep 22, 2015
In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.
Sep 15, 2015
Pharmaceutical Technology
Manufacturers challenge details in new policies designed to promote access to important therapies.
Sep 09, 2015
By Pharmaceutical Technology Editors
Mumbai-based Cipla agreed to acquire US companies InvaGen and Exelan, giving Cipla US tablet and capsule production capacity, a more diversified portfolio, and market access.
Sep 09, 2015
By Pharmaceutical Technology Editors
Lannett Company agreed to purchase Kremers Urban Pharmaceuticals, the US specialty generic-pharmaceuticals subsidiary of global biopharmaceuticals company UCB S.A., for $1.23 billion.
Sep 01, 2015
Pharmaceutical Technology
An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.
Aug 28, 2015
By Pharmaceutical Technology Editors
Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
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