Bioequivalency Vaccination Vaccine 
World of DTC Marketing
FEBRUARY 21, 2022
Pfizer expects to make as much as $22bn from its new Covid pill this year, on top of $37bn it made in 2021 from the vaccine. Pfizer’s Paxlovid currently costs about $530 for a five-day course of the treatment. Merck’s molnupiravir, now approved for use in the U.K., costs about $700. At this point, one must wonder why the U.S.
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.
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The Pharma Data
FEBRUARY 1, 2021
The addition of the IM administration of Plegridy to Biogen’s MS portfolio offers another important option at a time when MS patients are being encouraged to discuss their MS treatment and considerations around COVID-19 vaccination with their physicians.1,2 MS, the coronavirus and vaccines – updated global advice. percent vs. 32.1
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. Unlike small-molecule generic drugs, biosimilars do not need to demonstrate bioequivalence to the innovator product. What is a Biosimilar?
Worldwide Clinical Trials
MAY 30, 2024
Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.
The Pharma Data
DECEMBER 27, 2020
CureVac and the University Medical Center of Mainz launched a Phase III trial of CVnCoV, their COVID-19 vaccine candidate, in healthcare workers. The study will evaluate the safety and immunogenicity of the vaccine in a two-dose schedule of 12 micrograms.
The Pharma Data
AUGUST 9, 2021
Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. .” The U.S.
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