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.
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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.
The Remicade (infliximab) biosimilar market is segmented based on approved disease indications and regions.
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By Disease Indication
- Crohn’s disease
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Ulcerative Colitis
- Plaque psoriasis
- North America
- Western Europe
- Eastern Europe
- Asia Pacific excluding Japan
- Latin America