Pharma in Brief
FEBRUARY 8, 2024
The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).
Pharmaceutical Technology
OCTOBER 28, 2022
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
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Drug Discovery World
AUGUST 22, 2023
In September 2021, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the initiation of a pilot programme 1 to provide parallel scientific advice to pharma companies applying for marketing authorisation for generic versions of hybrid products and complex generic drug products.
Pharmacy Checkers
FEBRUARY 14, 2020
Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Several years later, the FDA ordered bioequivalence tests and finally, through those results, which found, like ConsumerLab.com did, that the People’s Pharmacy was right, and forced the drug off the market. Compare Wellbutrin Prices.
pharmaphorum
JANUARY 17, 2022
The company was slammed for restricting distribution of its drug so generic drug manufacturers couldn’t conduct bioequivalence tests or access a key ingredient used in the drug’s production.
The Pharma Data
DECEMBER 28, 2020
Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Glucagon is indicated for the treatment of severe hypoglycemia and is also used as a diagnostic aid.
XTalks
FEBRUARY 8, 2021
In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.
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