#biosimilars
昨天晚些时间
新召开的ODAC会议
给出了全票通过的结果
16票全部支持批准CT-P10
美首款Rituximab类似物即将获批上市
该产品来自trion
此前该产品已经于去年初
获EC批准在欧洲上市
在英荷以六到七折的价格销售
半年时间拿下30%市场份额
到了四季度
已经拿下英43%荷58%份额
欧洲市场还有Sandoz产品Riximyo
两款产品的上市销售
使得Roche原研产品美罗华
欧洲销售额在2017年下滑11%
而到了2018上半年
欧洲销售额已经下跌47%
MabThera/Rituxan sales in Europe
国内复星医药旗下复宏汉霖
已经在去年提交该类似物上市申请
并于年初获得国内有限审评资格
由于中信国健撤回注册申请
HLX-01也就有希望成为首款上市药物
目前国内进入III期的企业
还包括
海正、信达和神州细胞
trion, Inc. (Applicant) has submitted a biologics license application (BLA) under section 351(k) of the Public Health Service Act (PHS Act) for CT-P10, a proposed biosimilar to US- licensed Rituxan (rituximab) (BLA# 103705).
Treatment of adult patients with
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Relapsed or refractory, low grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent.
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Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
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Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.