Biosimilar refers to biotherapeutic product that is similar in terms of quality, efficacy, and safety to an existing licensed reference
therapeutic drug. Biological products are the fastest growing class of therapeutic products, as they offer additional treatment options
and help in lowering healthcare costs. 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.
On the basis of region, the global Remicade biosimilar market is segmented into North America, Latin America, Europe, Asia Pacific, Middle
East, and Africa. Europe holds a dominant position in the global Remicade biosimilar market and is expected to retain its dominance over
the forecast period, owing to the presence of top market players in the region, rapid entry of biosimilars in the European market as well
as high adoption rate due low price of the biosimilars. For instance, in 2018, Sandoz, a Novartis division received European Commission
(EC) approval for Zessly (infliximab) a remicade biosimilar for use in Europe. The successive research and speedy approvals by the U.S.
regulatory authorities for market entry of biosimilars in North America is expected to drive growth of the market over the forecast
period. For instance, in December 2017, Pfizer, Inc. received the U.S. FDA approval for second biosimilar, Ifixi to Janssen’s blockbuster
drug Remicade to treat rheumatoid arthritis.
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Furthermore, Asia Pacific is expected to witness significant growth in the market over the forecast period, owing to developments in
healthcare infrastructure and U.S. FDA approval of Remicade (infliximab) biosimilars by regional players to market the products
internationally. For instance, in April 2016, Celltrion- a South Korea-based manufacturing company received the U.S. FDA approval for
intravenously administered version of the rheumatoid arthritis drug sold under the name Infllectra. Moreover, major investments by
regional players for research and development of biosimilar production is expected to drive growth of the market in Asia. For instance, in
October 2016, Cipla, Inc. invested US$ 8 million to set up a manufacturing plant for biosimilars in South Africa.
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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