Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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Biological Products

(Recombinant DNA products) Samsung Bioepis
  • Registration Date 2016-10-14
  • Hit 2222

Company Information

1. Name

Samsung Bioepis

2. Website Address

www.samsungbioepis.com

3. Location

Songdo Site :

107, Cheomdan-daero, Yeonsu-gu, Incheon,

21987 Republic of Korea

4. Contacts

General : episinfo@samsung.com

Media : bioepispr@samsung.com

5. References

Pharmaceutical Product Information

1. Brand Name

BRENZYS®

2. Active Ingredient

Etanercept

3. Indication

[Korea]

Rheumatoid arthritis, Psoriatic arthritis, Axial spondyloarthritis (Ankylosing spondylitis and non-radiographic axial spondyloarthritis), Plaque psoriasis

4. Information

Following an approval in Sep 2015 in Korea, it was approved in EU (Jan 2016), Australia (Jul 2016) and Canada (Aug 2016)

BRENZYS® is a fusion protein which inhibits turnor necrosis factor alpha, known to modulate immune responses.

* BRENZYS® is commerciallized in EU as BENEPALI®.

Pharmaceutical Product Information

1. Brand Name

RENFLEXIS®

2. Active Ingredient

Infliximab

3. Indication

[Korea]

Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis, Psoriasis, Crohn's disease, Ulcerative colitis

4. Information

Following an approval in Dec 2015 in Korea, it was approved in EU (May 2016).

RENFLEXIS® is a monoclonal antibody(mAb) which inhibits turnor necrosis factor alpha, known to modulate immune responses.

* RENFLEXIS® is commerciallized in EU as FLIXABI®.

Attached File

Division

Written by 전형옥