Addressing a significant need by describing the science and process involved to develop
biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar …

Forum held on 22 January 2012 in San Francisco, CA, focused on selected scientific and
regulatory aspects in the development of biosimilar products. Such products are an …

Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of
action depends on multiple domains. Consequently regulatory approval of biosimilars of …

Worldwide sales of biologic drugs exceeded 100 billion USD in 2011. About 32% is from
therapeutic monoclonal antibody (mAb). With many blockbuster biopharmaceutical patents …

Limited access for high-quality biologics due to cost of treatment constitutes an unmet
medical need in the United States (US) and other regions of the world. The term “biosimilar” …

The pressure to contain rising healthcare costs—combined with the number of innovator
biologic drugs coming off patent (30 licensed biological drugs by 2015)—offers huge …

Monoclonal antibody (mAb) therapeutics, which currently have global sales of over US $50
billion, are starting to receive competition from biosimilar entrants. Driven by the prospect of …

The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory
framework for biosimilar has also been established in the US, Japan, and other countries. As …

European regulators laid out the rules for copying biotech's blockbuster monoclonal
antibody (mAb) therapies, paving the way for biosimilars developers to access the $36.4 …

Biosimilars are biotherapeutic products with similar efficacy, safety, and quality to a licensed
bio-originator. Biosimilars include monoclonal antibodies, soluble receptors, growth factors …