Clinical comparison of ABP 215 and bevacizumab in patients with NSCLC: Pharmacokinetic results and justification for extrapolation across bevacizumab indications.

TY - JOUR

T1 - Clinical comparison of ABP 215 and bevacizumab in patients with NSCLC: Pharmacokinetic results and justification for extrapolation across bevacizumab indications.

AU - Thatcher, Nick

AU - Thomas, Michael

AU - Pan, Zhiying

AU - Goldschmidt, Jerome H.

AU - Schenker, Michael

AU - Melara, Rebeca

AU - Hanes, Vladimir

N1 - 9050 Background: Approval of biosimilars is based on totality of evidence (TOE) that includes demonstration of analytical, functional, and pharmacokinetic (PK) similarity, and comparable clinical efficacy, safety, and immunogenicity. The TOE supports scientific justification for extrapolation across other indications that a share common mechanism of action (MOA).

PY - 2017/5/30

Y1 - 2017/5/30

UR - https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.9050

U2 - 10.1200/JCO.2017.35.15_SUPPL.9050

DO - 10.1200/JCO.2017.35.15_SUPPL.9050

M3 - Article

VL - 35

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

ER -