Biosimilars from a practicing rheumatologist perspective: An overview.

The earliest experimental trials of monoclonal antibodies took place in the early 1980s using murine monoclonal antibodies directed at human lymphoma and leukemia cell antigens. Since those early trials, therapeutic advances have produced monoclonal antibodies and fusion proteins that are now used in multiple disease states including cancers, autoimmune diseases, inflammatory bowel disease, psoriasis, neurologic disorders and others. Modern techniques have led to the development of multiple chimeric or fully humanized immunoglobulin, receptor and fusion proteins targeting cell markers, interleukins or other target proteins involved in pathophysiologic disease processes resulting in marked improvements in many different disease states. As novel innovator patents are about to expire, commercial entities are actively involved in creating follow-on agents that are similar to these original biologic innovator compounds. The hope and promise of these "biosimilars" to society is increased access to more patients at lower costs. The desire of manufacturers is product development at lower cost (lower research and development) with great potential for widespread use and sales. The challenge for regulators and authorities is to develop strategies that do not overlook the safety concerns of physicians and patients by excessively streamlining approval processes and overlooking potential efficacy and immunologic differences compared to the original innovator compounds.