US EditionBioRationality: Commemorating the 15th Anniversary of the BPCIA
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BioRationality: Commemorating the 15th Anniversary of the BPCIA
Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
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