During the first quarter, the Group was granted 2 clinical approvals, 3 production approvals, and 2 approvals for Consistency Evaluation, and made 4 clinical applications, 6 applications for Consistency Evaluation and 8 production applications after the completion of bioequivalency
. Cumulatively, a total of 501 pharmaceutical products had obtained clinical approval, or were under clinical trial or applying for production approval.
Among these RCTs, they observed that there was no evidence of the superiority of innovator to generic drugs and concluded that it is reasonable for physicians and patients rely on FDA bioequivalency
rating to judge clinical equivalence.
The Hatch-Waxman Act recognized the need for a published compendium of generics passing bioequivalency
, the Party shall not, without the consent of a person
A strict registration mechanism validates, among multiple quality controlling factors, the manufacturing conditions and drug bioequivalency
, enabling the government to control comparisons of generics to originators and to clearly indicate the equivalence.
This edition has been updated to include new findings in drug delivery and dosage form design and revised worldwide regulatory requirements, as well as new topics like the history of generic pharmaceuticals, new guidelines for submissions related to bioequivalency
studies, models of noninferiority, the biosimilarity of large molecule drugs, the bioequivalence of complementary and alternative medicines, biosimilar therapeutic proteins and monoclonal antibodies, new FDA guidelines for bioanalytical method validation, outsourcing and monitoring bioequivalence studies, and the future of the field.
"After prior consultation with the US FDA, Celltrion conducted additional clinical trials (starting on October 2013 and lasting 6 months) to determine the bioequivalency
of the originator products with Remsima.
The company added that the data from its Phase 1 trial of its anti-psoriasis drug candidate Prurisol for the conversion of Prurisol to abacavir is now within passing the Bioequivalency
"'stability data, dissolution rates, bioequivalency
(86) By overruling Bolar, the Hatch-Waxman Act allows a generic manufacturer to use a patented product to conduct bioequivalency
studies for the ANDA process.
(1) The Hatch-Waxman Act created an abbreviated pathway for generic versions of brand drugs to get Food and Drug Administration (FDA) approval by permitting the use of brand clinical studies to show bioequivalency
in the Abbreviated New Drug Application (ANDA) because the active ingredients are identical.