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.
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.
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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