医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

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

2015年09月08日 PM09:30
このエントリーをはてなブックマークに追加


 

KENILWORTH, N.J. & SEOUL, South Korea

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).

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150908005550/en/

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 collaboration.

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 www.samsungbioepis.com 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, visit www.merck.com and connect with us on Twitter, Facebook 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 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).

View source version on businesswire.com: http://www.businesswire.com/news/home/20150908005550/en/

CONTACT

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

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • ADCセラピューティクスが当社の新規抗体薬物複合体ADCT-402の第I相中間データを発表
  • Vedanta Biosciences Granted Four New U.S. Patents Expanding Coverage for Compositions and Methods of Use for Therapeutics Based on Microbiome-Derived Bacterial Consortia
  • Daiichi Sankyo and Puma Biotechnology Announce Research Collaboration with Major Cancer Center in HER2-Mutated Cancer
  • 武田和Seattle Genetics呈报3期ECHELON-1临床试验的阳性数据,该试验评估ADCETRIS® (brentuximab vedotin)用于晚期霍奇金淋巴瘤的一线治疗
  • ADCセラピューティクスが当社の新規抗体薬物複合体ADCT-301の第I相中間データを発表