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Pfizer has reported positive results for its monoclonal antibody PF-06410293, a biosimilar of the heavy bomb drug AbbVie Humira that the company is developing. Humira is an anti-TNF monoclonal antibody that has annual sales of nearly $15 billion for inflammatory disease adaptations.
said the REFLECTIONSB538-02 study reached the main end of its trial. The American Rheumatology Society 20 (ACR20) measured the response rate of moderate to severe rheumatoid arthritis in week 12 and demonstrated that the therapeutic effect was equivalent to Humira (Adamo monoanti).
Pfizer noted that in the past four months, PF-06410293 was the second inflammatory biosimilar to propose positive top-line results and the third to propose positive top-line results.
Currently in the United States, the European Union and other markets have approved the drug's adaptation certificates include: rheumatoid arthritis, early idynetic arthritis, psoriasis arthritis, hyperarmline spina bifidostitis, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, plaque psoriasis, septic sweat adenitis and staphylococcitis.
September 2016, U.S. regulators opened the green channel for AbbVie's biologics, Amgen's Amjevita's first biosimilar. (Sina Medical News)