Camargo
NOVEMBER 11, 2020
Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. In October, the U.S.
XTalks
FEBRUARY 8, 2021
While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?
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Camargo
DECEMBER 13, 2021
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.
FDA Law Blog
FEBRUARY 26, 2024
Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”
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.
Druggist
MARCH 25, 2021
Read more about initiating the treatment with a progestogen-only pill in the product information leaflet. Product information leaflets for both Cerelle and Cerazette list precisely the same common and uncommon side effects. Source: *Cerelle product information leaflet, **Cerazette product information leaflet .
The Pharma Data
DECEMBER 17, 2020
With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. Ampholipad received scale-up production approval in June 2020, allowing a production capacity of over a million vials a year. SOUTH SAN FRANCISCO, Calif.
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