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Biosimilars

机译:生物仿制药

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摘要

Biologic agents are complex protein monoclonal antibodies such as adalimumab and ustekinumab, and genetically engineered recombinant fusion proteins such as etanercept. These agents have added greatly to the therapeutic armamentarium in treating moderate to severe psoriasis. Patients with severe psoriasis are at an increased risk for depression, diabetes, and cardiovascular disease.1 Unfortunately, these biologic agents access to patients with moderate to severe psoriasis are often limited because of their cost. A National Psoriasis Foundation (NPF) 2007 study reveled that over 50% of patients with moderate to severe psoriasis in the United States of America are treated only with topical therapy.2 Armstrong et al reviewing an NPF survey from 2003-2011 determined that 25% of patients with moderate to severe psoriasis were not receiving any treatment.3 Treatment with biologic agents have not only proven to be extremely efficacious in the treatment of psoriasis, they have also shown to improve quality of life and decrease depression and anxiety. Unfortunately, access is often limited due their excessive cost, which inhibits a large percentage of psoriasis patients from receiving biologic treatment. The recent and future expiry of data protection or patents for the first biologic agents has opened the door to developing biological products similar to these products.
机译:生物制剂是复杂的蛋白质单克隆抗体,例如阿达木单抗和ustekinumab,以及基因改造的重组融合蛋白,例如依那西普。这些药物在治疗中度至重度牛皮癣时已大大增加了治疗装备。患有严重牛皮癣的患者患抑郁症,糖尿病和心血管疾病的风险增加。1不幸的是,由于成本昂贵,这些生物制剂对中度至重度牛皮癣患者的获取途径通常受到限制。美国国家银屑病基金会(NPF)2007年的一项研究表明,在美国,超过50%的中度至重度银屑病患者仅接受局部治疗。2Armstrong等对2003-2011年NPF调查进行的回顾发现,有25% 3中至重度银屑病患者未接受任何治疗。3用生物制剂治疗不仅已被证明对银屑病非常有效,而且还改善了生活质量并减轻了抑郁和焦虑。不幸的是,由于其过高的成本,访问常常受到限制,这抑制了很大比例的牛皮癣患者接受生物治疗。第一种生物制剂的数据保护或专利的近期和未来期满为开发与这些产品相似的生物产品打开了大门。

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