Generic Drugs/Biosimilars

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.
Aug 02, 2017
Pharmaceutical Technology
FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 
Aug 01, 2017
By Pharmaceutical Technology Editors
FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.
Jul 25, 2017
By Pharmaceutical Technology Editors
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
Jul 12, 2017
By Pharmaceutical Technology Editors
The company has entered into a settlement agreement with generic-drug companies to resolve patent litigation.
Jul 05, 2017
By Pharmaceutical Technology Editors
A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.
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