Merck Announces Samsung Bioepis Receives Approval of RENFLEXIS™ (Infliximab), a Biosimilar of Remicade, in Korea


December 7, 2015 8:00 am ET

Samsung Bioepis’ Second Immunology Biosimilar Approved, to be Commercialized Under Partnership with Merck

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that Samsung Bioepis Co., Ltd. has received approval of
RENFLEXIS™ (infliximab), a biosimilar of the immunology medicine
Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. Merck
will commercialize Samsung Bioepis’ RENFLEXIS in Korea as part of
Merck’s commercialization partnership with Samsung Bioepis to offer
high-quality biosimilar alternatives to existing biologic medicines.

Samsung Bioepis’ RENFLEXIS is indicated in Korea for the treatment of
rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease,
ulcerative colitis, psoriatic arthritis and plaque psoriasis in adult
patients (age 18 years and older). Merck plans to launch RENFLEXIS in
South Korea in the first half of 2016.

“Merck is committed to delivering on the promise of biosimilars and we
look forward to bringing RENFLEXIS forward to help meet the needs of
physicians, patients and healthcare systems,” said Dora Bibila, general
manager, Merck Biosimilars.

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

About the Merck and Samsung Bioepis collaboration

Merck and Samsung Bioepis announced in February 2013 a development and
commercialization agreement under which Merck will commercialize
multiple biosimilar candidates in certain partnered territories. Under
terms of the agreement, Samsung Bioepis is responsible for preclinical
and clinical development, process development and manufacturing,
clinical trials and regulatory registration. Under a separate
development and commercialization agreement with Samsung Bioepis
announced in February 2014, Merck is responsible for the development,
registration, manufacturing and commercialization of MK-1293 (insulin
glargine) worldwide.

Merck will be responsible in its partnered territories for
commercialization of the following biosimilar candidates in immunology,
oncology and diabetes [Merck partnered territories]:

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

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 these 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, oncology and diabetes.
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen.
For more information, please visit:

About Merck

Today’s Merck is a global health care 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 health care through
far-reaching policies, programs and partnerships. For more information,
and connect with us on Twitter,
and LinkedIn.

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Pamela Eisele, 267-305-3558
Robert Consalvo, 908-236-1127
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1879

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