Commercial development of therapeutic monoclonal antibodies (MAbs) began in the early 1980s, and by 1986 the first MAb product had been approved in the United States: muromonab-CD3 (trade name Orthoclone OKT3, marketed by Janssen-Cilag) for prevention of kidney-transplant rejection. Since its approval, therapeutic MAbs and antibody-related products such as Fc-fusion proteins, antibody fragments, and antibody–drug conjugates (collectively referred to herein as “MAb productsâ€) have grown to become the dominant product class within the biopharmaceutical market. They have been approved for…