Drug Discovery World
JULY 23, 2024
Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with an already licensed reference medicine, called Isentress. Studies have been limited to tests to determine that it is bioequivalent to the reference medicine.
Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. In October, Antares Pharma licensed Ferring Pharmaceuticals’ Nocdurna® (desmopressin acetate) sublingual tablet , which was approved in 2018 for the same indication as Noctiva and has a boxed warning highlighting the same risks.
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Camargo
DECEMBER 13, 2021
A biologics license application (BLA) is required for biological products subject to licensure under the PHS Act, and FDA approval to market a biologic is granted by issuance of a biologics license. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
pharmaphorum
JANUARY 18, 2023
NewAmsterdam said it is now selecting a formulated fixed-dose combination tablet of obicetrapib plus ezetimibe that will be tested in a phase 3 trial, as well as a study to make sure the formulation is bioequivalent to each drug delivered separately. Amgen licensed the rights to NewAmsterdam in 2020.
FDA Law Blog
FEBRUARY 26, 2024
On February 23—the same day that the Agency licensed SIMLANDI (adalimumab-ryvk) Injection , the first interchangeable high-concentration, citrate-free biosimilar to HUMIRA, and that qualifies for First Interchangeable Exclusivity (“FIE”)—FDA denied the Boehringer Petition. FDA explained that its bioequivalence regulations at 21 C.F.R.
XTalks
FEBRUARY 8, 2021
Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. If the FDA licenses an interchangeable, that means that switching between the interchangeable and the reference doesn’t increase the safety risk or decrease the effectiveness compared to using the reference only,” says Brahme.
The Pharma Data
AUGUST 5, 2020
In February, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab for the treatment of relapsing forms of multiple sclerosis in adults. J Neurol Sci. 2003;206(2):165–71.
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