英德市场表现抢眼，Samsung Bioepis生物类似药Q1业绩1.75亿美元
The following article is from 药融投资 Author 药融圈发布
1
4月24日，韩国生物药明星企业Samsung Bioepis披露2019年第一季度业绩。公司生物类似药板块2019Q1营收1.75亿美元；2018年Q1为1.28亿美元。
恩利（Enbrel）生物类似药Benepali贡献1.24亿美元；
Infliximab,英夫利昔单抗生物类似药Flixabi贡献1500万美元；
2018年10月上市的阿达木单抗生物类似药Imraldi贡献3600万美元。
在英国和德国，Samsung Bioepis的Imraldi表现抢眼。
中国区合作：
此前在2019年1月7日，三生制药宣布与Samsung Bioepis达成一项合作协议，将在中国大陆（不包括香港、澳门和台湾地区）进行三星Bioepis多个生物类似药在研产品的临床研发和商业化，其中包括贝伐珠单抗的生物类似药在研产品SB8。
2019年2月，Samsung Bioepis与康桥资本签署协议，共同在中国国内进行生物类似药的临床开发、注册及商业化合作。Samsung Bioepis和康桥资本将在中国合作开展赫赛汀（Herceptin）生物类似药SB3（成分名称：Trastuzumab）、雷珠单抗（Lucentis）生物类似药SB11（成分名称：Ranibizumab）和依库珠单抗（Soliris）生物类似药SB12（成分名称：Eculizumab）的临床试验、许可和商业化。
截止201903的Pipeline
附原文：
During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.
Biogen, which together with its partner Samsung BioLogics forms Samsung Bioepis, reported its first quarter 2019 financial results on April 24.
The partnership has 3 biosimilars that are currently in the marketplace: a biosimilar etanercept (Benepali) referencing Enbrel; Imraldi, referencing Humira; and a biosimilar infliximab, sold as Flixabi in the European Union and as Renflexis in the United States, referencing Remicade.
Benepali sales were up 3% year over year, for a total of $124 million in revenue. Flixabi was up 123% year over year, for $15 million in revenue. Imraldi, which was launched in October 2018, was up 114% quarter over quarter, for $36 million in revenue.
These numbers come after reports that biosimilar adalimumab in general—and Imraldi in particular—are off to a strong start in Europe. IQVIA data released in the first quarter of the year show that in Germany, which had the most biosimilar adalimumab options available in November 2018, the greatest percentages of patients who switched from Humira to another option were transitioned to Imraldi (37%). Sandoz’s Hyrimoz and Amgen’s Amgevita trailed behind at 15% and 12%, respectively.
In the United Kingdom, which was responsible for the most consumption of brand-name Humira in the European Union as of September 2018, Imraldi was awarded 45% of the market via a centralized tender. Amgevita and Sandoz were each awarded roughly one-fourth of the market, and Mylan’s Hulio was awarded approximately 5% of the market.
According to IQVIA, “It is Samsung with Imraldi that has won out so far in the 2 markets that matter the most: Samsung has the largest potential market in the United Kingdom and has shown the most success in acquiring Humira patients in Germany.”
Samsung Bioepis continues to develop other biosimilar agents; currently in the drug maker’s pipeline are FDA- and European Medicines Agency–approved trastuzumab biosimilar Ontruzant, a bevacizumab biosimilar undergoing a phase 3 study, a ranibizumab biosimilar undergoing a phase 3 study, and an eculizumab biosimilar currently in phase 1 clinical trials.