Camargo
DECEMBER 13, 2021
Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. One common characteristic for most if not all biologics is the triggering of an immune response or anti-drug antibodies.
The Pharma Data
AUGUST 5, 2020
About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. 10% of patients 1.
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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
Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study of monoclonal antibody VIR-7831 for hospitalized adults with COVID-19. The drug is a humanized IgG4 monoclonal antibody that blocks CCR5 and is being developed for COVID-19, HIV and metastatic triple-negative breast cancer.
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