[November 20, 2015] |
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Samsung Bioepis Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union
Samsung (News - Alert) Bioepis Co., Ltd. today announced that the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion on Benepali® - a biosimilar
version of Enbrel® (etanercept), previously known as SB4 -
for the treatment of rheumatoid arthritis, psoriatic arthritis, axial
spondyloarthritis (ankylosing spondylitis and non-radiographic axial
spondyloarthritis) and plaque psoriasis. This marks the first time the
CHMP has adopted a positive opinion on an etanercept biosimilar.
The CHMP's positive opinion will now be referred to the European
Commission (EC) which will review and decide on the grant of a marketing
authorization for Benepali®. If a marketing authorization is
granted, Benepali® will be the first etanercept biosimilar to
be approved in the European Union (EU).
"We are very pleased to have developed the first etanercept biosimilar
to receive a positive CHMP opinion," said Christopher Hansung Ko, CEO of
Samsung Bioepis. "By leveraging our strengths in product development and
quality assurance, we will continue to focus on developing affordable,
high-quality biologic treatment options for patients in Europe who need
these life-enhancing medications."
This positive CHMP opinion on Benepali® was based on Phase 1
and Phase 3 clinical studies that tested the biosimilarity of Benepali®
to Enbrel®. In the 52-week Phase 3 clinical study, which
involved 596 patients randomized across 70 sites in 10 countries,
Benepali® demonstrated comparable safety and equivalent
efficacy to Enbrel®, as evidenced in ACR20 response rate of
80.8% in the Benepali® arm versus 81.5% in the Enbrel®
arm.
In addition to Benepali®, Samsung Bioepis has been developing
two other anti-tumor necrosis factor-alpha (anti-TNF-a) investigational
biosimilar candidates, the latest clinical study results for whih are
as follows:
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SB2 investigational biosimilar candidate to Remicade®
(infliximab): On November 9, 2015 at the Annual Meeting of the
American College of Rheumatology (ACR) and the Association for
Rheumatology Health Professionals (ARHP) in San Francisco, Samsung
Bioepis announced 54-week SB2 clinical study results that showed
comparable safety and equivalent efficacy to Remicade®, as
evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2%
in the Remicade® arm. The SB2 study randomized 584 patients
with moderate to severe rheumatoid arthritis despite methotrexate
therapy across 73 sites in 11 countries. In March 2015, Samsung
Bioepis submitted to the EMA (News - Alert) a Marketing Authorization Application for
SB2, for which a CHMP opinion has yet to be announced.
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SB5 investigational biosimilar candidate to Humira®
(adalimumab): On November 10, 2015 at the ACR/ARHP Annual Meeting
in San Francisco, Samsung Bioepis announced 24-week Phase 3 clinical
study results that showed comparable safety and equivalent efficacy to
Humira®, as evidenced in ACR20 response rate of 72.5% in
the SB5 arm versus 72.0% in the Humira® arm. The study
randomized 544 patients with moderate to severe rheumatoid arthritis
despite methotrexate therapy across 52 sites in seven countries.
About Samsung Bioepis Co., Ltd. Samsung
Bioepis was established in 2012 with a mission to develop affordable,
high-quality biopharmaceutical products and to provide better patient
access to life-enhancing medications. The company aims to be the world's
leading biopharmaceutical company through innovations in product
development and quality assurance.
Samsung Bioepis has commercial agreements with Biogen and Merck to
commercialize and distribute biosimilar products in immunology and
oncology. The products and geographic responsibilities include:
Biogen
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SB4, investigational biosimilar candidate referencing Enbrel®
(etanercept) - European Union, Switzerland, Japan
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SB2, investigational biosimilar candidate referencing Remicade®
(infliximab) - European Union, Switzerland, Russia, Turkey
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SB5, investigational biosimilar candidate referencing Humira®
(adalimumab) - European Union, Switzerland, Russia, Turkey
Merck
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SB4, investigational biosimilar candidate referencing Enbrel®
(etanercept) - Worldwide, but excluding United States, European Union,
Switzerland, Japan
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SB2, investigational biosimilar candidate referencing Remicade®
(infliximab) - Worldwide, including United States, but excluding
European Union, Switzerland, Russia, Turkey
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SB5, investigational biosimilar candidate referencing Humira®
(adalimumab) - Worldwide, including United States, but excluding
European Union, Switzerland, Russia, Turkey
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SB3, investigational biosimilar candidate referencing Herceptin®
(trastuzumab) - Worldwide
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen.
For more information, please visit www.samsungbioepis.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151120005300/en/
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