The use of therapeutic monoclonal immunoglobulin G (IgG) monoclonal antibodies (mAb) has grown significantly after the first commercialization of muromonab (Orthoclone OKT3®) in 1986  due to their desirable features such as long serum half‐lives, limited off‐target toxicity, and high specificity and potency [2,3]. Five of the top 10 selling drugs in 2017 are mAbs, namely adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), bevacizumab (Avastin®), and trastuzumab (Herceptin®) [4,5]. mAb is the best‐selling class of biologics with global annual revenue of nearly $100 billion, which represents approximately half of the total sales of all biopharmaceutical products [6,7]. It is anticipated that there will be ∼70 mAb products on the market by 2020 and combined worldwide sales of nearly $125 billion .
Table 13.1 List of approved mAbs in Europe (European Medicine Agency, EMA) and US (Food and Drug Administration, FDA) for pediatric indications.
|Name of the mAb||Approved indication in pediatric||Approved age range||Administration||Type||Source|
|Adalimumab||Crohn's disease Polyarticular juvenile idiopathic arthritis||≥6 yrb ≥4 yra; ≥2 yr b|