Biosimilars and biobetters as tools for understanding and mitigating the immunogenicity of biotherapeutics.

In this article, we review key steps for the development of biosimilars and biobetters and related bioanalytical challenges, with a focus on how they are associated with immunogenicity. We analyze the factors that can impact antidrug antibody (ADA) responses and their correlations with preclinical and clinical outcomes to provide relevant insights and to answer questions, including what types of aggregate are immunogenic. We also address strategies for developing less-immunogenic biotherapeutics.

Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data.

Context: HIV patients treated with antiretroviral therapy (ART) often develop increased visceral adipose tissue (VAT).

Objective: Our objective was to perform a pooled analysis of two phase-3 studies of tesamorelin in ART-treated HIV patients with excess abdominal fat.

Design And Setting: Two multicenter, international studies were conducted; a 26-wk randomized, placebo-controlled primary intervention phase was followed by a 26-wk safety extension.