Generic Drugs/Biosimilars

Feb 08, 2018
Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.
Feb 02, 2018
Pharmaceutical Technology
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Jan 25, 2018
By Pharmaceutical Technology Editors
Growth is expected for the generic drugs and biosimilars sectors, driven by cost pressures on healthcare systems.
Jan 19, 2018
By Pharmaceutical Technology Editors
Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.
Jan 16, 2018
By Pharmaceutical Technology Editors
The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
Jan 03, 2018
By Pharmaceutical Technology Editors
The agency published draft guidance on good practices for submitting abbreviated new drug applications.
Dec 05, 2017
By Pharmaceutical Technology Editors
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
Dec 02, 2017
Pharmaceutical Technology
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.
Nov 27, 2017
By Pharmaceutical Technology Editors
In the wake of generic-drug pricing pressure and declining revenues, Teva has restructured its commercial business and made executive leadership changes.
Nov 20, 2017
By Pharmaceutical Technology Editors
Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.
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