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. 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.
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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. 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.
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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