Bioequivalency Generic Drugs Manufacturing Marketing 
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 ).
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
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. billion, three biosimilar products in development targeting products with a market size of approximately $13.0
Pharmaceutical Technology
JULY 25, 2022
With decreasing margins on the horizon, pharma manufacturers have long shown an interest in specialty generics, which is only expected to rise in the future. Specialty generics is a term used to refer to generic versions of drugs that are often expensive, complex, or “high touch”—requiring significant involvement of service to manage.
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.
Druggist
MARCH 25, 2021
In terms of prescribing, both contraceptives are regarded as the same drug. . Although the active ingredient is the same, there are differences in non-active components (the core of the tablet and coating), which reflect both pills’ manufacturing process. Bioequivalent studies may involve humans or animals (EMA, 2012). .
Expert insights. Personalized for you.
52 
Let's personalize your content