The competition among pharmaceutical companies to carve out a larger share of the market for Rituximab is intensifying.
Rituximab treats certain autoimmune diseases and types of cancer. The drug treats non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, idiopathic thrombocytopenic purpura, pemphigus vulgaris and myasthenia gravis.
Currently, Roche’s Rituxan dominates the global Rituximab market. It was the fourth most-sold drug globally in 2016, with an annual sale of $8.58 billion. However, after the patent protecting Rituxan expired in Europe in 2013 and U.S. in that year, biosimilars started to challenge its dominance.
Celltrion’s Truxima was the first Rituximab biosimilar to enter the market. The drug has gradually increased its share after receiving sales approval in the EU. The company is also waiting for approval in the U.S.
As a result of the cutthroat competition, Rituxan saw sales plummet. Rituxan’s sales fell 16 percent year-on-year in the third-quarter of 2016 in Europe. During that time, Truxima gained 7 percent of the total Rituximab market share in EU.
Sandoz, a Novartis division, is next in line with the company receiving sales approval in the EU in June last year while filing for approval in the U.S.
Pfizer and Samsung BioLogics are also aiming to claim their shares of the Rituximab market.
Pfizer announced on Wednesday that its Rituximab biosimilar, PF-05280586, received positive results from phase 3 clinical trials. With the success of the test, the company is expected to apply for sales approval both in the U.S. and EU.
Samsung BioLogics is also planning to launch SAIT101, its biosimilar version of Rituxan.
Archigen Biotech, a 50-50 joint venture between Samsung BioLogics and AstraZeneca, has initiated phase 3 clinical trials for a new Rituxan biosimilar in South Korea while starting phase 1 clinical trials in the U.S.
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