Biosimilars are almost identical copies of the originally approved drugs and can be manufactured only when the patent for the original innovator drug expires. These products are highly sensitive to smallest changes in manufacturing procedure, as these drugs possess high molecular complexity. Remicade (Infliximab) refers to a chimeric monoclonal antibody biologic licensed by U.S. FDA in 1998, as an innovative product indicated for the treatment of Crohn’s disease in adults and children. The monoclonal antibody drug was first developed in partnership by Janssen Biotech, Inc. and Merck & Co. The Remicade was later approved for its use in the treatment of ulcerative colitis, plague psoriasis, rheumatic arthritis, and spinal psoriatic arthritis in combination with methotrexate. Later, various pharmaceutical manufacturers developed biosimilars to infliximab, which lowered market share of Remicade due to cost-effective prices.
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Increasing incidence of autoimmune diseases such as plaque psoriasis and rheumatoid arthritis are expected to drive growth of the Remicade biosimilar market size. According to the American Autoimmune Related Disease Association, around 50 million American suffered from autoimmune diseases in the U.S. in 2017.
Moreover, faster reaction rates of these biosimilars due to their availability in the form of intravenous mode of administration is further expected to increase the adoption of Remicade biosimilar over the forecast period. Furthermore, patent expiry of the branded versions is expected to increase the number of biosimilars for its branded counterparts thereby increasing the demand for Remicade biosimilar. However, stringent regulatory guidelines for development of these biosimilars as well as side effects of these drugs leading to risk of hospitalization are expected to restrain growth of the global Remicade biosimilar market.
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Key players operating in the global remicade biosimilar market include Janssen Biotech, Inc., Merck and Company, Inc., Alvogen, Pfizer, Inc., Celltrion, Nippon Kayaku, Napp Pharmaceuticals, and others. Market players are focused on introducing maximum number of biosimilar for multiple indications to retain their position in the global market. For instance, in July 2017, Merck & Company, Inc. in collaboration with Samsung Bioepis introduced Renflexis (infliximab-abda), a biosimilar to Remicade for the treatment of moderate to severe Crohn’s disease, active ulcerative colitis, rheumatoid arthritis, and other few disease indications.
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