Monoclonal antibodies (mAbs) have established themselves as the leading
biopharmaceutical therapeutic modality. The establishment of robust manufacturing …

Advances in molecular biology and molecular genetics as well as major scientific
breakthroughs in immunology and oncology have led to the rapid growth of biologic …

Objective To understand the levels of awareness, usage, and knowledge of biosimilars
among patients, caregivers, and the general population in the US and the European Union; …

BACKGROUND: Several authors have hypothesized that adverse drug events (ADEs) upon
switching from reference biologics to biosimilar products are related to the nocebo effect …

The current processing paradigm of large manufacturing facilities dedicated to single
product production is no longer an effective approach for best manufacturing practices …

Background Some experts have proposed combating rising drug prices by promoting brand–
brand competition, a situation that is supposed to arise when multiple US Food and Drug …

The biopharmaceutical industry is evolving in response to changing market conditions,
including increasing competition and growing pressures to reduce costs. Single‐use (SU) …

Biologic agents have an increasingly important role in clinicalcare, accountingfor22%
ofnewUSFoodandDrug Administration (FDA) drugapprovalsfrom2010-2015and comprising …

Expanded and updated, this is a new edition of an essential look at the history, structure,
successes, and problems of the US health care system. The United States spends more on …

Importance Brand-name drugs, including biologics, have been the primary source of
increasing prescription drug spending in the US. Each state has drug product selection laws …