Generic Drugs

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The agency published draft guidance on good practices for submitting abbreviated new drug applications.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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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.
Nov 07, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.
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.
Sep 07, 2017
By Pharmaceutical Technology Editors
Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.
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.
Aug 04, 2017
By Pharmaceutical Technology Editors
Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.
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