Drug Patent Watch
DECEMBER 10, 2024
Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts. This knowledge is critical in designing bioequivalence studies and ensuring that generic drugs have the same therapeutic effect as the brand-name drug.
Drug Patent Watch
OCTOBER 7, 2024
PK studies help ensure that generic drugs are bioequivalent to their brand-name counterparts, meaning they have similar absorption, distribution, metabolism, and excretion (ADME) profiles. Pharmacokinetics (PK) plays a crucial role in the development and approval of generic drugs.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Drug Patent Watch
DECEMBER 12, 2024
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period.
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.
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.
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.
Expert insights. Personalized for you.
94 
Let's personalize your content