5th adamumumab bio generic! Pfizer abrila Da (adalimumab afzb) has been approved by the US FDA!

November 19, 2019 / abrilada, a bioequivalent drug developed by BIOON / - Pfizer Adalimumab afzb (adalimumab, adalimumab) has recently been approved by the FDA of the United States It is a bionic drug of HUMARA (adalimumab, adalimumab), the flagship product of Alberta, which is used to treat a variety of autoimmune diseases, including rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PSA), ankylosing spondylitis (as), adult Crohn's disease (CD), ulcerative colitis (UC), plaque psoriasis This FDA approval is based on a review of a comprehensive data package that demonstrates the biological similarity of abrilada to the reference drug Humira This includes the results of the clinical comparative study of reflections b538-02 This is a randomized, double-blind, parallel group phase III clinical study conducted in patients with moderate to severe active rheumatoid arthritis (RA) who received methotrexate (MTX) treatment for inadequate remission The combination of abrilada subcutaneous injection (40 mg subcutaneously every other week) and methotrexate treatment scheme was evaluated as compared with Humira subcutaneous injection (40 mg subcutaneously every other week) The efficacy, safety and immunogenicity of combined methotrexate therapy The results showed that there was no clinically significant difference in efficacy, safety and immunogenicity between abrilada and Humira So far, FDA has approved a total of 25 biosimilars Abrilada is the 9th biosimilar drug approved by FDA in 2019, and the 5th adamumumab biosimilar drug approved by the agency so far In addition to Pfizer's abrilada, four other approved biological generic drugs of adalimumab are: hadlima (Samsung bioepis / MSD, July 2019), hyrimoz (Novartis, October 2018), cyltezo (bringer ingelham, August 2017), and amjevita (amjevita, September 2016) As the flagship product of EBV, Humira is the first approved anti-tumor necrosis factor TNF - α drug in the world, which is also the best-selling anti-inflammatory drug in the world Since its launch, it has been approved by more than 90 countries in the world, and has been approved for more than 10 indications, including rheumatoid arthritis There are juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, psoriasis, purulent sweat gland inflammation and uveitis Humira is a super heavyweight product of Aberdeen It has been the world's "medicine king" for several consecutive years In 2018, the global sales reached US $19.936 billion, including US $13.685 billion of net revenue in the U.S market and US $6.251 billion of net revenue in the international market (most from Europe) In Europe, a number of adamumab biosimilars have been listed in Europe, but in the U.S market, Alberto has successively reached a settlement agreement with nine pharmaceutical companies, including Amgen, Samsung bioepis / MSD, mylan, Sandoz, Fresenius kabi, momenta, Pfizer, coherus Biosciences and bringer ingelham According to the terms of the agreement, adamumumab biosimilars of these companies can be launched in the U.S market at different time points in 2023, and will not be listed in advance due to the listing of products of other authorized companies Statement from Sarah Yim, M.D., acting director of the office of theoretical biology and biosimilar s in the FDA's Center for drug evaluation and research, on FDA's continued progress facilitating competition in the biological market place with approval of 25th biosimilar product