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.
Pharma in Brief
FEBRUARY 8, 2024
On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.
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Camargo
NOVEMBER 11, 2020
Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks. The generic drug must also have the same labeling as the RLD (except for differences permitted under the Agency regulations).
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.
FDA Law Blog
FEBRUARY 26, 2024
FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. Boehringer’s regulatory argument got no further traction. do not help Boehringer’s case. parenteral solutions) but is not typically broken out for others (e.g.,
Camargo
DECEMBER 13, 2021
The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. CBER regulates products under a variety of regulatory authorities: INDs for CBER-regulated products. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. BLA process (CBER).
FDA Law Blog
JULY 6, 2021
Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.
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