Camargo

NOVEMBER 11, 2020

announced a collaboration to develop a companion diagnostic for Vitrakvi® (larotrectinib) NTRK (neurotrophic tropomyosin receptor kinase) inhibitor, approved in the U.S. In October, less than 18 months later, the FDA approved the companion test, which will allow physicians to better identify target eligible patients.

Development 242

Development Bioequivalency Generic Drugs Production 242

The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved.

FDA Approval 40

FDA Approval Bioequivalency Clinical Trials Clinical Trials 40

Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Section 351(a) is the traditional pathway for approving biologics under the PHS Act. The role of pharmacometrics for biosimilars is no less significant than for biologics.

Development 161

Development Production Immune Response Licensing 161