Merck and Samsung Bioepis Announce Approval of BRENZYS™ (Etanercept), a Biosimilar of Enbrel, in Korea


September 8, 2015 7:30 am ET

First Product from Global Partnership to Deliver High-Quality Biosimilars to Help Meet Needs of Patients and Healthcare Systems Worldwide

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Samsung Bioepis Co., Ltd. today announced the approval of BRENZYS™
(etanercept), a biosimilar of the immunology medicine Enbrel, by the
Ministry of Food and Drug Safety (MFDS) in Korea. BRENZYS is indicated
for the treatment of rheumatoid arthritis, psoriatic arthritis, axial
spondyloarthritis (non-radiographic axial spondyloarthritis and
ankylosing spondylitis) and psoriasis in adult patients (age 18 years
and older).

The approval of BRENZYS in Korea represents the first product approval
under Merck’s collaboration with Samsung Bioepis, which is designed to
offer high-quality biosimilar alternatives to existing biologic
medicines to help address patient and healthcare system needs worldwide.
Merck plans to launch BRENZYS in South Korea by the end of this year or
early next year.

“We are very excited to receive this first regulatory approval of a
biosimilar product resulting from our late-stage development pipeline,”
said Christopher Hansung Ko, CEO of Samsung Bioepis. “The approval of
BRENZYS in Korea is especially gratifying, and underscores our
commitment to advancing healthcare through innovation and groundbreaking
technology. We look forward to building on this progress in our
collaboration with Merck.”

“The approval of BRENZYS in Korea is a key milestone in Merck’s
longstanding commitment to improving access to important medicines,”
said Dora Bibila, general manager, Merck Biosimilars. “We are excited by
the opportunity to deliver on the promise of biosimilars overall – and
on the promise of BRENZYS – by combining Merck’s deep global customer
expertise with the extensive development and manufacturing capabilities
of Samsung Bioepis.”

Merck’s launch of BRENZYS will include comprehensive education and
support services for healthcare professionals, patients and their
caregivers, including biosimilars education, disease education, and
reimbursement and access support.

The approval of BRENZYS in Korea was supported by rigorous analytical
structural and functional testing, as well as a Phase 1 crossover
pharmacokinetics study and a Phase 3 clinical study comparing BRENZYS to
the originator medicine.

About the Merck and Samsung Bioepis collaboration

Merck and Samsung Bioepis announced in February 2013 a collaboration to
develop and commercialize in certain partnered territories multiple
biosimilar candidates. In February 2014, the two companies expanded the
collaboration to include MK-1293, an insulin glargine biosimilar
candidate currently in Phase 3 clinical development for the treatment of
patients with type 1 and type 2 diabetes. Under terms of the agreement,
Samsung Bioepis is responsible for preclinical and clinical development,
process development and manufacturing, clinical trials and regulatory
registration, except for MK-1293, which Merck will continue to develop
and manufacture. Merck will be responsible in its partnered territories
for commercialization of all approved products resulting from the

The portfolio includes biosimilar candidates in immunology, oncology and
diabetes. There are five candidates in Phase 3 development [Merck
partnered territories]:

  • SB4 Enbrel (etanercept) [worldwide ex-U.S./EU/Japan]
  • SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]
  • SB5 Humira (adalimumab) [worldwide ex-EU/Russia/Turkey]
  • SB3 Herceptin (trastuzumab) [worldwide]
  • MK-1293 Lantus (insulin glargine) [worldwide]

Additional regulatory filings for each of these five biosimilar
candidates are expected to occur in the 2015-2016 timeframe.

About Samsung Bioepis

Samsung Bioepis was established in 2012 as part of the Samsung group.
The company’s mission is to produce affordable, high-quality
biopharmaceutical products for diseases with high unmet medical,
humanistic and economic needs. The company aims to be the world’s
leading pharmaceutical company with its effort for innovation and
advanced technologies. Please visit
for more information.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information,
and connect with us on Twitter,
and YouTube.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
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rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of the company’s patents
and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2014 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (

Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879
Samsung Bioepis
Jamyung Cha, (82) 32-455-6137
Sungjoon Park, (82) 32-455-6120

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