European Pharmaceutical Review
DECEMBER 19, 2022
3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. This is reflected in the legal basis for biosimilars under Article 6 of Regulation 726/2004 and Article 10(4) of Directive 2001/83 (as amended by Directive 2004/27).
European Pharmaceutical Review
DECEMBER 12, 2023
As a biotech, what work does Innate Pharma do in the biopharma industry? A favorable safety profile was also observed. Beyond Sezary Syndrome, lacutamab showed also preliminary safety and efficacy in TELLOMAK on the first 21 patients having KIR3DL2-expressing Mycosis fungoides with an encouraging global response rate of 28.6
Pharmaceutical Technology
FEBRUARY 20, 2023
On the other hand, a lack of diversity in clinical trial populations, particularly when the disease population is significantly underrepresented, greatly diminishes the quality of data obtained for drug safety and efficacy profiles. Hans Bunschoten: Viroclinics was founded in 2001, spun out of a university setting.
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