Generic Drugs

Jul 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
Jul 08, 2016
A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.
Jul 06, 2016
By Pharmaceutical Technology Editors
Teligent is expanding its manufacturing and R&D complex in New Jersey.
Jun 15, 2016
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
Jun 10, 2016
By Pharmaceutical Technology Editors
Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.
Jun 01, 2016
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
May 10, 2016
The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.
Apr 14, 2016
By Pharmaceutical Technology Editors
The Office of Generic Drugs highlights the agency’s work to advance generic drugs.
Feb 18, 2016
By Pharmaceutical Technology Editors
The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.
Feb 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
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