Generic Drugs/Biosimilars

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.
Mar 22, 2017
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
Feb 24, 2017
By Pharmaceutical Technology Editors
In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
Feb 15, 2017
By Pharmaceutical Technology Editors
The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.
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