Bioequivalency Branding Regulation 
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.
Drug Patent Watch
DECEMBER 30, 2024
The ANDA must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is the original brand-name drug approved for marketing in Japan. Pharmaceutical Regulations in Japan 2020. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs. Freyr Solutions.
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Pharmaceutical Technology
JULY 25, 2022
Unlike biosimilars, it is simpler for small molecule specialty generics to establish equivalence to their branded forms, explains Vasquez. Watanabe refers to the example of Teva’s immunomodulator drug Copaxone used for the treatment of multiple sclerosis, which the company produced and marketed as its own branded product.
Drug Patent Watch
JANUARY 14, 2025
Why Generic Drugs Matter Generic drugs are the Robin Hoods of the pharmaceutical world, stealing from the rich (brand-name drugs) and giving to the poor (our wallets). They offer the same therapeutic benefits as their brand-name counterparts but at a fraction of the cost. But how do companies develop these cost-effective alternatives?
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.
XTalks
FEBRUARY 8, 2021
Like generic forms of synthetic pharmaceuticals, biosimilars have the advantage of being less costly compared to their branded counterparts. While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023.
Delveinsight
FEBRUARY 5, 2021
The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. 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. However, it is possible.
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