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 the agency.
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.
The Remicade (infliximab) biosimilar market is segmented based on approved disease indications and regions.
By Disease Indication
Asia Pacific excluding Japan
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, Asia Pacific excluding Japan, Japan and Middle East & Africa.
In terms of geography, Europe dominates the Remicade 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 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.
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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Supply & Demand
Competition & Companies involved
Regional analysis includes:
North America (U.S., Canada)
Latin America (Mexico. Brazil)
Western Europe (Germany, Italy, France, U.K, Spain, Nordic countries, Belgium, Netherlands, Luxembourg)
Eastern Europe (Poland, Russia)
Asia Pacific (China, India, ASEAN, Australia & New Zealand)
Middle East and Africa (GCC, S. Africa, N. Africa)
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