Generic Drugs/Biosimilars

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.
May 15, 2017
Pharmaceutical Technology
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
May 05, 2017
By Pharmaceutical Technology Editors
Forecasts were lowered, Reuters reported, due to reduced drug approvals and increased competitive pressures.
May 05, 2017
By Pharmaceutical Technology Editors
EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.
Apr 24, 2017
By Pharmaceutical Technology Editors
Sandoz has received positive opinions from EMA’s CHMP for its biosimilars rituximab and etanercept for all indications of their respective reference medicines.
Apr 13, 2017
Pharmaceutical Technology spoke with CPhI North America presenter Jonathan Helfgott to discuss navigating GDUFA and helpful tips for submitting successful ANDAs.
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