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December 7, 2015 8:00 am ET

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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.

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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.

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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: www.samsungbioepis.com.

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, visit www.merck.com and connect with us on Twitter, Facebook, YouTube and LinkedIn.

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.

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Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest 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 (www.sec.gov).