Remicade Biosimilar
Market
Share, Global Trends,
Analysis, Research, Report,
Opportunities,
Segmentation and Forecast,
2016-2026
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Description
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About the drug and drug class:
Biosimilar can be defined as a type of biological product that is highly similar to an already
FDA approved drug, known as reference biological product. Biosimilars are drugs licensed by
U.S. FDA and European Medicine Agency (EMA) and reflect no clinical and meaningful
differences from the reference products in terms of safety, purity, efficacy and effectiveness.
These biosimilar drugs can only be approved for the indications and conditions that have
been previously approved for the reference product by big regulatory agencies.
Remicade (infliximab) is a monoclonal antibody originally produced by Janssen Biotech Inc.,
and Merck & Co. (MSD) in partnership and licensed by the U.S. FDA in 1998. It is used in the
treatment of Crohn’s disease in both adult and pediatric patients. Additionally it is also used
for treatment of active ulcerative colitis, moderate to severe rheumatoid arthritis in
combination with methroxate, spinal and active psoriatic arthritis, and plaque psoriasis. The
U.S. FDA has approved a biosimilar drug similar to Remicade, named Inflectra, on 05 April,
2016, which is expected to erode the market share of Remicade due to lower competitive
pricing. Inflectra (infliximab dyyb) is sold in the European market, after receiving an approval
from the EMA’s CHMP in June, 2013 under the brand name Remsima (developed by South
Korea’s Celltrion Healthcare and marketed by Pfizer’s Hospira). The drug Remsima is sold at a
discount of 30% than that of original Remicade in 11 European markets including UK, France,
Germany and Italy. Another Japanese company, Nippon Kayaku launched Infliximab BS in
Japan on 28 November 2014 – however, the Japanese license only covers Crohn’s disease,
rheumatoid arthritis and ulcerative colitis indications. The U.S. FDA has now launched
Remicade’s biosimilar Inflectra, which is only the second biosimilar drug to be approved by
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Drivers and Restraints:
Drivers for the Remicade biosimilar include rising incidence of autoimmune diseases
particularly rheumatoid arthritis and plaque psoriasis, early patent expiry of the branded
version, discounted pricing across the European market and faster reaction times due to
intravenous mode of administration. Further, entry of biosimilar version could provide
financial relief on healthcare systems and improve patient’s accessibility to essential
medication.
Barriers of the Remicade biosimilar include serious side effects associated with the use of
drug that could lead to hospitalization or even be fatal. These include tuberculosis, bacterial
sepsis, invasive fungal infections (such as histoplasmosis) and others. As such, manufacturer
of the drug has been mandated to include a “Boxed Warning” to alert both healthcare
professionals and patients. Further, complex nature of the molecule and lack of FDA
approved facilities for manufacturing the drug are factors that could restrain the growth of
the drug’s market in developing regions.
Market Segmentation:
The Remicade (infliximab) biosimilar market is segmented based on approved disease
indications and regions.
By Disease Indication
Report
Description
Report Description
•Crohn’s disease
•Rheumatoid arthritis
•Ankylosing spondylitis
•Psoriatic arthritis
•Ulcerative Colitis
•Plaque psoriasis
By Regions
•North America
•Western Europe
•Eastern Europe
•Asia Pacific excluding Japan
•Japan
•Latin America
•MEA
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Description
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Market Overview:
Early loss of patent exclusivity is one the major factors that could fuel attractive market
growth of the Remicade biosimilar over the forthcoming years. Rising prevalence of relevant
autoimmune disorders coupled with discounted pricing of the Remicade biosimilar in
European markets are factors expected to contribute to increased referral and consumption
of the drug. Development of faster approval procedures and proper U.S. FDA approved
manufacturing facilities in the regional nodal countries are factors that contribute to
increased drug uptake. Further, distinct naming and transparent labeling to ensure correct
prescribing and dispensing and enhanced post-marketing surveillance are factors that could
contribute largely towards prescriber confidence, and enhanced market uptake of the drug
over the coming years. However, safety issues concerning manufacturing facilities along with
potential side effects of drug consumption could hamper for acceptance of infliximab
biosimilar over the long run.
Remicade Biosimilar Market: Region- wise Outlook:
Depending on geographic regions, global Remicade biosimilar market is segmented into
seven key regions: North America, South America, Eastern Europe, Western Europe, and Asia
Pacific excluding Japan, Japan and Middle East & Africa.
In terms of geography, Europe dominates the Regicide biosimilar market, followed by Japan
and Latin America. The prime reason for the same is the launch of the biosimilar version
soon after the patent expiry of the branded version. However, systematic and faster drug
review process is expected to create revenue traction in markets over North America and
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Description
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other regions. Stringent regulatory approval procedures and streamlined manufacturing
guidelines, particularly in the Central and South American nations, could lead to
development of effective regional manufacturing and distribution strategies for Remicade
biosimilars. Finally, rising government support for development of biosimilar drugs and low
switching tendency from physicians secure the future market growth of the biosimilar in the
near term.
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Remicade Biosimilar Market: Key Players:
Some of the key market players in Remicade (infliximab – mAb) market are Janssen Biotech
Inc., Merck &Co., Pfizer Inc. (AC. Hospira), Celltrion Inc., Alvogen, Napp Pharmaceuticals, and
Nippon Kayaku.
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