Infliximab is a chimeric anti-TNF monoclonal antibody approved for the treatment of Crohn's disease. It is also approved to treat other autoimmune diseases such as psoriasis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and others. It is marketed under the trade name remicade. It was developed by Jansen Biotech (Johnson & Johnson) doing business as Centocor and was approved by the US Food Drug Administration (FDA) in 1998 and the European Medicines Agency in 1999. It was originally approved for the treatment of Crohn's disease , however as of 2011, has been approved for various indications including rheumatoid arthritis. The patent for infliximab expired in Europe in February 2015 and will expire in the United States in September 2018. Biosimilars are defined as biotherapeutic products that have similar safety and efficacy to an approved biologic product. Pfizer's Hospira subsidiary, in collaboration with Celltrion, launched the first biosimilar of infliximab, namely Inflectra, in the United States in April 2016 and in Europe in June 2013, so the entry of the biosimilar into the market has stimulated the growth of the market of infliximab biosimilars. In addition to this, increasing incidence and prevalence of autoimmune diseases, emergence of new participants, increasing accessibility of infliximab, and eroding prices have spurred the growth of the infliximab biosimilars market. However, the rigorous regulatory process for approving biosimilars restrains market growth. Furthermore, the complex nature of the molecule, extended patent term, unavailability of FDA-certified manufacturing facilities, and low trend of switching from brand to biosimilar hinder the growth of the infliximab biosimilar market. Based on application, the infliximab biosimilars market is segmented into Crohn's disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis, and others. Say no to plagiarism. Get a tailor-made essay on "Why Violent Video Games Shouldn't Be Banned"? Get Original Essay The segment of Crohn's disease followed by rheumatoid arthritis is expected to grow rapidly during the forecast period due to increasing incidence and prevalence rate. It is estimated that 1-10 cases per 100,000 people have Crohn's disease. In terms of end user, the global infliximab market is segmented into hospital pharmacy, retail pharmacy, and online pharmacy. The online pharmacy segment is expected to grow at a higher pace due to the increase in the number of Internet usage, availability of various options for the buyer with attractive offers and ease of use. Regionally, the global infliximab market is segmented into North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. Europe dominates the infliximab biosimilar market, this is due to less stringent regulatory requirements, early entry of the infliximab biosimilar into the European market (infliximab biosimilar has been available in Europe since 2013), early loss of exclusivity of patents and the entry of new participants. Furthermore, the increasing incidence and prevalence of chronic diseases and the increase in geriatric population have stimulated the growth of the market in Europe. North America holds the second position in the global infliximab biosimilar market due to strong infliximab biosimilar pipeline, rising research and development expenditures, and increasing government initiatives. Please note: this is just an example. Get a custom paper from our expert writers now. Get an essay.
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