Generic Drugs/Biosimilars

Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Aug 25, 2017
By Pharmaceutical Technology Editors
The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.
Jul 05, 2017
By Pharmaceutical Technology Editors
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency announced it is taking steps to increase competition within the prescription drug market.
Jun 23, 2017
By Pharmaceutical Technology Editors
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
Jun 21, 2017
By Pharmaceutical Technology Editors
FDA Commissioner Scott Gottlieb announced the agency will hold a public meeting on drug competition as part of its Drug Competition Action Plan.
May 30, 2017
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
May 16, 2017
By Pharmaceutical Technology Editors
The agency released several new and revised guidance documents regarding product-specific generic drug development.
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