다빈치정보<- 바로가기 INCHEON, KOREA--( / )--Samsung Bioepis Co., Ltd. announced today that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two biosimilar candidates under development by Samsung Bioepis, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia. SB11, a biosimilar candidate referencing LUCENTIS®[ii] (ranibizumab), is undergoing phase 3 clinical trial, while SB15, a biosimilar candidate referencing EYLEA®[iii] (aflibercept), is in pre-clinical development.
In addition, the agreement provides Biogen an option to extend the commercialization term for Samsung Bioepis’ three anti-TNF biosimilars - BENEPALI™ (etanercept), FLIXABI™ (infliximab), and IMRALDI™ (adalimumab) - in Europe for additional five years, extending the original ten-year agreement.[1] BENEPALI™ is the most prescribed etanercept in France, Germany, Italy, Spain, and the United Kingdom (UK).[iv] IMRALDI™ is the leading adalimumab biosimilar in Europe.[iv]
The agreement also provides Biogen an option to receive commercialization rights to BENEPALI™, FLIXABI™ and IMRALDI™ in China in exchange for royalties on sales in the market.
The agreement is a testament to Samsung Bioepis’ strong track record in the field of biosimilars and the potential value that Samsung Bioepis’ ophthalmology biosimilars could deliver to patients and healthcare systems across the world. Under the agreement, Samsung Bioepis will receive upfront payments of USD 100 million, up to USD 270 million in milestone/option payments, as well as sharing of sales revenue. Samsung Bioepis will be responsible for development, regulatory registration, and manufacture of the products, while Biogen will be responsible for commercialization.
“In Europe, we have been very pleased with Biogen’s commercialization efforts with our anti-TNF medicines, fulfilling the mission of expanding access to high-quality medicines to patients across Europe. By building on this collaboration, we are excited to potentially expand the opportunity for patients living with ophthalmological conditions, who don’t have access to life-changing medicines,” said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”
Samsung Bioepis’ products are now available across Europe, North America, Asia, Oceania, and Latin America. The company currently has four biosimilars approved and marketed across Europe, which include the anti-TNF trio of BENEPALI™ (etanercept), FLIXABI™ (infliximab) and IMRALDI™ (adalimumab), as well as an oncologic biosimilar, ONTRUZANT® (trastuzumab). In the United States, the company has one biosimilar - RENFLEXIS® (infliximab-abda) - approved and marketed. ONTRUZANT® (trastuzumab-dttb) received approval from the U.S. Food and Drug Administration (FDA) in January 2019, while ETICOVO™ (etanercept-ykro) and HADLIMA™ (adalimumab-bwwd) received FDA approval in April and July 2019, respectively.
[1] The effective dates of commercialization differ for each anti-TNF product based on the launch dates. BENEPALI™ and FLIXABI™ were launched in Europe in January and May 2016, respectively, while IMRALDI™ was launched in October 2018 in Europe.
About BENEPALI™ (etanercept)
BENEPALI™ (etanercept), a biosimilar referencing ENBREL®[v], was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis, pediatric plaque psoriasis. BENEPALI™ is currently available in 25 countries in Europe and is the most prescribed etanercept in France, Germany, Italy, Spain and the United Kingdom.[iv]
About FLIXABI™ (infliximab)
FLIXABI™ (infliximab), a biosimilar referencing REMICADE®[vi], was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI™ can also be used in patients 6-17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI™ is currently available in 17 countries in Europe.[iv]
About IMRALDI™ (adalimumab)
IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®[vii], was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, uveitis, and pediatric uveitis. IMRALDI™ is currently available in 19 countries in Europe and is the leading adalimumab biosimilar in Germany and in Europe year to date 2019.[iv, viii]
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: and follow us on social media - Twitter, LinkedIn.
[i] Data on file: Biogen, Inc. Third Quarter 2019 Financial Results and Business Update, Oct 22, 2019
[ii] LUCENTIS® is a registered trademark of Genentech
[iii] EYLEA® is a registered trademark of Regeneron Pharmaceuticals
[iv] Data on File: IQVIA, GERS, Insight Health ODV
[v] ENBREL® is a registered trademark of Pfizer/Amgen
[vi] REMICADE® is a registered trademark of Janssen
[vii] HUMIRA® is a registered trademark of AbbVie
[viii] Data on File: Biogen data on file
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INGELHEIM, GERMANY--( / )--Results from a survey analysing the prescribing behaviour of 500 European physicians treating patients with advanced non-small cell lung cancer (NSCLC) have been published in Clinical Lung Cancer. The research examined the primary therapy goal of physicians and their choice of treatment for patients with advanced adenocarcinoma 다빈치다운로드 홀덤방법 of the lung, after first-line chemotherapy. An overview of the 썰저장소 INGELHEIM,methodology and results can be 다빈치다운로드 viewed here.
Key results 다빈치다운로드 of the survey showed that:
· 40% of physicians surveyed considered extending overall survival a priority therapy goal for patients with a good performance status; 60% 다빈치다운로드 of physicians stated that their primary 다빈치다운로드 게이만화 goal was related to either maintaining quality of life (36%), achieving disease stability (19%) or tumour response (5%)
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· Generally, physician attitudes towards therapy goals for these patients were aligned across 다빈치다운로드 욕정 all countries surveyed (France, Germany, Italy, Spain and the 다빈치다운로드 프로토 하는법 UK)
Lead author, Professor Nicolas Girard of University Hospital of Lyon, France, commented, “The delicate balance between efficacy and tolerability has been the main consideration in the choice of treatments with modest efficacy for 다빈치다운로드 여성작업제 patients with advanced lung cancer. In the rapidly evolving lung cancer treatment landscape and with better treatments becoming available, extension of survival whilst 다빈치다운로드 해외스포츠배팅 maintaining a good quality of life is now a realistic objective for advanced lung cancer patients, even after chemotherapy.”
To complement the findings from the physician survey, research on patient expectations 다빈치다운로드 농구토토배당률 and therapy goals was carried out to understand how they align with the views of treating physicians. In a roundtable discussion the consensus amongst European patient advocacy groups was that extending overall survival, rather than disease stabilisation or 다빈치다운로드 처방비용 quality of life, was the primary goal for the majority of 섹스녀 Tolung cancer patients.
Aoife McNamara, Irish Cancer Society commented, “A diagnosis of advanced lung cancer can be an overwhelming experience but ensuring a patient and physician are aligned on the goal of therapy, 다빈치다운로드 주사제 choice of treatment and expected outcomes, will often provide the best outcome for that individual. As such, a holistic patient experience which is built around a partnership with their physician and their circumstances, provides 토렌트쇼미 Aoife다빈치다운로드 포미스터정 solid basis for choosing the most appropriate treatment.”
The physician prescribing behaviour survey was sponsored by Boehringer Ingelheim as part of their ongoing commitment to improving lung cancer care in an area of high unmet medical 다빈치다운로드 야구경기일정 need.
Dr Jorg Barth, Corporate Senior Vice President, Therapy 다빈치다운로드 야구랭킹결과 Area Head Oncology, Boehringer Ingelheim said, “It’s critical that physicians are aware of the full range of benefits offered by current therapy options in order to feel confident in prescribing treatments which effectively meet the needs of patients. 섹시녀 Drremain committed to improving the lives of lung cancer patients and we hope sharing the results of this research helps to increase understanding and communicate learnings about physician and patient attitudes to treatment choices.”
The physician prescribing behaviour 나체 Thewhich was carried out between March and April 2015 is published in the journal Clinical Lung Cancer. A corresponding insights report on the drivers of treatment decisions by patients and physicians 다빈치다운로드 for advanced NSCLC after chemotherapy entitled “Advanced Non-Small Cell Lung Cancer: 다빈치다운로드 Balancing Therapy Goals and Treatment Choices” is now available online 다빈치다운로드 축구토토매치 here.
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This press release is issued from our Corporate Headquarters 다빈치다운로드 축구토토사이트 in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval 다빈치다운로드 시알리스필름 status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have 유앤미 Thisissued in the countries where we do business.
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