2015/1/22 12:20


AsiaNet 59277(0103)




*承認ならSB4は欧州ではバイオジェン・アイデック(Biogen Idec)が販売

サムスン・バイオエピス(Samsung Bioepis Co.,Ltd.)は21日、エンブレル(Embrel、一般名etanercept)バイオシミラー候補のSB4がEMAの実証試験を受け、審査のために受け付けられたと発表した。MAAマークの受け付けは初のエンブレルのバイオシミラーがEUの規制審査にまで前進したことを示している。MAAは中程度から重症の関節リウマチ(RA)患者を対象にした第III相臨床試験の結果による。








サムスン・バイオエピスは2012年にサムスン・グループの一部門として設立され、手ごろな価格で高品質のバイオ医薬製品を必要としている多くの患者のために生産することを使命としている。同社はイノベーションと先進技術を引き継ぐ世界の有力なバイオ医薬品会社になることを目指している。詳しい情報はwww.samsungbioepis.com へ。

ソース:Samsung Bioepis

European Medicines Agency Accepts Samsung Bioepis' Enbrel(R) Biosimilar Candidate, SB4, for Regulatory Review


INCHEON, South Korea, Jan. 21, 2015 /PRN=KYODO JBN/ --

-- First biosimilar from Samsung Bioepis to advance to EMA regulatory review --

-- First Enbrel biosimilar to be filed in the EU --

-- If authorized, SB4 will be marketed in Europe by Biogen Idec --

Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization

Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4, has

been validated and accepted for review by European Medicines Agency (EMA). The

acceptance of the MAA marks the first Enbrel biosimilar to advance into

regulatory review in the European Union (EU). The MAA is based on results from

a Phase III clinical trial in patients with moderate-to-severe rheumatoid

arthritis (RA).

In Europe, Enbrel is indicated for the treatment of a number of rheumatic

diseases, including moderate to severe RA, certain forms of juvenile idiopathic

arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If

authorized by the EMA, SB4 could be available for use in all of the same

indications as Enbrel.

"This MAA validation represents a significant milestone for Samsung Bioepis in

our work to develop and manufacture world-class biosimilars. More

significantly, it offers an opportunity to provide high-quality and effective

therapies for broadening access to patients in Europe," said Christopher

Hansung Ko, chief executive officer of Samsung Bioepis.

If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec.

It will also be produced at the company's manufacturing facility in Hillerod,

Denmark which is one of the largest biologic manufacturing facilities in the


In addition to the European filings, Samsung Bioepis intends to move forward

with additional applications for regulatory approvals in other territories


About the SB4

Samsung Bioepis previously conducted SB4 Phase 1 and Phase 3 clinical studies.

The MAA for the etanercept biosimilar was based on data from a Phase 3,

controlled, randomized, multicenter study in Europe where SB4 demonstrated its

comparability to Enbrel(R). The primary and secondary endpoints of the

study were assessed and met the qualification standard for the MAA submission.

Full data from the study will be available later this year.

About Samsung Bioepis

The company was established in 2012 as part of the Samsung group, with the

mission to produce affordable, high-quality biopharmaceutical products to many

patients in need. The company aims to be the world leading biopharmaceutical

company with its heritage of innovation and advanced technologies. Please visit

www.samsungbioepis.com for more information.

SOURCE  Samsung Bioepis