Pharmacy Checkers
FEBRUARY 14, 2020
Many readers complained that it just wasn’t cutting it compared to the brand name version. Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. a generic with the exact same formulation as the brand) of Wellbutrin XL available. Just switch back to the brand!”
Pharmaceutical Technology
OCTOBER 28, 2022
To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug. For biosimilars, however, this process is slightly more complex.
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World of DTC Marketing
FEBRUARY 21, 2022
A new study estimates the causal effects of coupons for branded drugs without bioequivalent generics using variation in coupon introductions over time and comparing differential responses across enrollees in commercial and Medicare Advantage plans. At this point, one must wonder why the U.S. About those copay cards.
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.
Drug Discovery World
AUGUST 22, 2023
In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. When it comes to peptides, more than 80 were approved in the US alone, with 8% of FDA branded drug approvals being for peptides during 2016-2021.
XTalks
FEBRUARY 8, 2021
Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. MYTH: Treatment-experienced patients cannot be prescribed biosimilars.
Delveinsight
FEBRUARY 5, 2021
Whenever the branded drugs go off-the-market, it paves the way for the entry of generics in the market. Generic medications are the same as the original branded ones, but cheaper. Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Generics in the Market.
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