Demand for biological products is high for the treatment of a large number of diseases. However, demand for biosimilar products is increasing to lower health care costs. Biosimilar products are derived in reference to biological products and have similar safety, efficacy, purity, and effectiveness when compared to the original products. Biosimilar can be characterized as a sort of biologic item that is profoundly like an as of now FDA approved biologic drug, known as reference drug.
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Biosimilars are drugs approved by the U.S. FDA and the European Medicine Agency (EMA) and show no clinical and meaningful difference from the reference biological product. These biosimilar products can be approved only for indications which are previously approved for the reference biological product by authorized regulatory bodies.
In 1998, the U.S. FDA licensed Remicade (infliximab), a monoclonal antibody originally produced by Janssen Biotech, Inc. and Merck & Co. in partnership. Its primary indication included Crohn’s disease in both adult and pediatric patients. It is also indicated for the treatment of ulcerative colitis, spinal psoriatic arthritis, plague psoriasis, and rheumatic arthritis when given in combination with methotrexate. The U.S. FDA approved biosimilar to Remicade named Inflectra on April 05, 2016.
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Pfizer launched Inflectra in the market at 15% discount on the original market price of the reference product. However, in April 2017, another biosimilar Renflexis (infliximab-abda), a tumor necrosis factor to Remicade by Samsung Bioepis and Merck & Co., was approved to be launched into the market. It is approved for almost all the indications that were approved under Remicade such as ulcerative colitis, spinal psoriatic arthritis, plague psoriasis, rheumatic arthritis, and ankylosing spondylitis.
Increase in incidence of autoimmune disorders such as rheumatoid arthritis, and psoriasis, patent expiry of branded drugs, and rise in health care costs drive the Remicade biosimilar market. Additionally, faster entry of Biosimilars into the Europe market leads to cost reduction and faster medicines accessibility help to grow this market. However, serious side effects associated with the drug could lead to fatality. This factor restraints the market.
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The global Remicade biosimilar market can be segmented based on approved indication and region. In terms of approved indication, the market can be categorized into ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis. Ulcerative colitis and rheumatoid arthritis show higher demand due to increase in number of cases of these diseases. Psoriasis also increase market demand owing to increase in the cases of autoimmune diseases. Based on region, the global Remicade biosimilar market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America dominates the market owing to high incidence of autoimmune diseases and increase in geriatric population. Europe is the second largest market for Remicade. Easy access to biosimilar medications in the region drives the market. India, southeast Asia, and China are emerging markets for biosimilar medicines because of changing lifestyle and increase in healthcare facilities in these regions.
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Key players in the global Remicade biosimilar market comprise Alvogen, Napp Pharmaceuticals, Janssen Biotech, Inc., Merck &Co., Pfizer, Inc., Cell Trion, and Nippon Kayaku.
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