Generic Drugs/Biosimilars

Aug 27, 2015
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
Aug 05, 2015
By Pharmaceutical Technology Editors
US generics manufacturer Amneal acquires a former J&J plant in Ireland.
Jul 09, 2015
By Pharmaceutical Technology Editors
Teva has launched the generic version of almotriptan malate (Axert), 6.25 mg and 12.5 mg, in the United States.
Jun 19, 2015
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency takes action against websites that illegally sell unapproved medications.
Jun 15, 2015
By Pharmaceutical Technology Editors
BPTF seeks changes in performance goals and fee payment schedule in GDUFA renegotiations.
Jun 09, 2015
By Pharmaceutical Technology Editors
The product, marketed as Sirdupla in the United Kingdom, is the generic version of GSK’s beta agonist and corticosteroid combination treatment for asthma.
Jun 08, 2015
In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”
May 27, 2015
Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.
May 27, 2015
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
May 22, 2015
As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.
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