#biosimilars
2018.09.20
欧洲CHMP推荐批准三家企业培非格司亭
Sandoz、Cinfa以及Mylan
三款产品依次为
Ziextenzo、Pelmeg、Fulphila
Cinfa Biotech
来自西班牙成立于2013年
在昨天
Mundipharma宣布
收购西班牙生物技术企业Cinfa
以增强在生物类似物领域的竞争力
”
Our biosimilars platform is a key component of our growth strategy and today’s acquisition is the obvious next step in us ensuring we remain agile and innovative in the biosimilars space.
—— Alberto Martinez
President and CEO, Mundipharma International Ltd
在生物类似物市场领域
Mundipharma
已经与trion有过合作经验
先后合作过两款类似物产品
Remsima®（Infliximab）
Truxima®（Rituximab）
截至2017年底
为当地医疗系统节约3.3亿欧元支出
”
After having successfully developed and manufactured our first biosimilar, we strongly believe Mundipharma is best placed to take Pelmeg® forward through the Cinfa Biotech acquisition. They have the pedigree and proven track record of launching biosimilars in Europe, have built strong partnerships with payers, hospital specialists and decision makers and have the deep local understanding of complex tender environments.
—— Enrique Ordieres
President of Infarco the parent company of Cinfa Group
培非格司亭
2017年美国销售额39亿美元
目前已经有Mylan的Fulphila获批上市
全球非美市场销售额6亿美元
目前有上述三家获CHMP推荐批准
Mundipharma Strengthens Position as a Leader in Biosimilars with Acquisition of Development Company Cinfa Biotech
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Deal includes global rights to pegfilgrastim biosimilar, Pelmeg® with a potential global market worth $4.5bn1
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Mundipharma acquires 100% ownership from parent company Infarco
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As a leader in biosimilars in Europe, today’s deal deepens Mundipharma’s biosimilars platform beyond commercial excellence to development
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Mundipharma estimates that through its existing partnership with trion – Remsima® and Truxima® have saved healthcare systems approximately €330m2
CAMBRIDGE, England–(BUSINESS WIRE)–The Mundipharma global network of independent associated companies has today added development capabilities to its biosimilars platform with the purchase of biosimilars development company Cinfa Biotech.
The announcement sees the Mundipharma network (including NAPP Pharmaceuticals in the UK) gain immediate access to Pelmeg® (B12019), a biosimilar to Neulasta® (pegfilgrastim), which received CHMP recommendation for approval on 20thSeptember 2018.
Alberto Martinez, President and CEO, Mundipharma International Ltd, “Our biosimilars platform is a key component of our growth strategy and today’s acquisition is the obvious next step in us ensuring we remain agile and innovative in the biosimilars space.
“We have successfully demonstrated our commercial excellence in biosimilars by building a market leading platform. Through our partnership with trion on Remsima® and Truxima® we estimate savings for healthcare systems of approximately €330m2 from launch to the end of 2017. By acquiring Cinfa Biotech we have now taken the first step in our plans to, not only expand our biosimilars footprint, but to develop future biosimilars which will continue to afford healthcare systems further savings and, in some cases, wider access for patients.”
Pelmeg® (originator Neulasta®3) is a pegylated version of granulocyte-colony stimulating factor (G-CSF) for the treatment of chemotherapy-induced neutropenia that works by stimulating the bone marrow to produce more neutrophils, thereby reducing the incidence of infection.
With a non-US market worth of $603mllion1 and originator patents already expired, pegfilgrastim biosimilars offer an exciting market opportunity.
Enrique Ordieres, President of Infarco the parent company of Cinfa Group, commented, “After having successfully developed and manufactured our first biosimilar, we strongly believe Mundipharma is best placed to take Pelmeg® forward through the Cinfa Biotech acquisition. They have the pedigree and proven track record of launching biosimilars in Europe, have built strong partnerships with payers, hospital specialists and decision makers and have the deep local understanding of complex tender environments.”
-Ends-