Patents for the first generation of approved biopharmaceuticals have either expired or are
about to expire. Thus the market is opening for generic versions, referred to as …

It has been over four decades since the development of monoclonal antibodies (mAbs)
using a hybridoma cell line was first reported. Since then more than thirty therapeutic …

Biologics such as monoclonal antibodies are much more complex than small-molecule
drugs, which raises challenging questions for the development and regulatory evaluation 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 …

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

Therapeutic monoclonal antibodies and related products have steadily grown to become the
dominant product class within the biopharmaceutical market. Production of antibodies …

There are a considerable number of biopharmaceuticals that have been approved for
clinical use in the past decade. Over half of these new generation drugs are glycoproteins …

The European Medicines Agency (EMEA) workshop on biosimilar monoclonal antibodies
(mAbs), held July 2, 2009 at the EMEA headquarters in London, was a harbinger with …

The development of analytical tools for the characterization of large biomolecules is an
emerging and rapidly evolving area. This development activity is motivated largely by the …

An In Vitro Comparative Immunogenicity Assessment (IVCIA) assay was evaluated as a tool
for predicting the potential relative immunogenicity of biotherapeutic attributes. Peripheral …