Antibody Cosmetics Regulation 
The Pharma Data
JUNE 20, 2025
Characterized by intensely itchy skin , painful fluid-filled blisters , lesions , and extensive redness , BP is not just cosmetically disfiguring—it significantly disrupts daily life, reduces mobility, and increases susceptibility to infection due to skin breakdown. Dr. George D.
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).
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FDA Law
FEBRUARY 29, 2024
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. Patent and Trademark Office (“PTO”) Patent Term Extension (“PTE”) decisions under 35 U.S.C. § That did not happen.
The Pharma Data
APRIL 30, 2021
Global Botox Cosmetic net revenues were $477 million , an increase of 44.7 Botox Cosmetic*. Global Venclexta net revenues were $405 million , an increase of 27.9 percent on a reported basis, or 24.5 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.141 billion , an increase of 34.9 Imbruvica d.
Pharma in Brief
JANUARY 10, 2024
However, many details remain to be addressed in forthcoming regulations. CIPO consulted on proposed features of the regulations in 2023 (see here ), including many factors that would reduce the length of the PTA term. Draft regulations are expected to be released for consultation in 2024. The Guidance was last updated in 2005.
XTalks
FEBRUARY 8, 2021
They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. The regulator allows biosimilars to show slight differences in clinically inactive components of a product. What is a Biosimilar?
The Pharma Data
NOVEMBER 21, 2020
Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Hahn , M.D.
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