Business Wire

SB5, An Adalimumab Biosimilar Referencing Humira®, Accepted for Review by European Medicines Agency

18.7.2016 01:05 | Business Wire

Del

The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the European Medicines Agency (EMA). The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (Nasdaq: BIIB). Earlier this year, the European Commission approved BENEPALI® (etanercept), a biosimilar referencing Enbrel®2, and FLIXABI® (infliximab), a biosimilar referencing Remicade®3.

Humira is approved in the European Union (EU) for use in moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn's disease, and moderate to severely active ulcerative colitis.

“The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “At an estimated $4Bn a year,i Humira is among the EU’s largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of healthcare systems.”

The MAA is based on a robust preclinical and clinical data package comparing SB5 with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humiraii and a Phase III, randomized, double-blind, multicenter study, in which SB5 demonstrated comparable efficacy, safety, and immunogenicity to Humira in patients with RA.iii The primary endpoint of the Phase III study, the ACR20 score response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that SB5 has a comparable safety and immunogenicity profile to Humira.iii

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

Biogen Safe Harbor
This press release includes forward-looking statements, including statements about the potential indications for SB5, and the approval of SB5 in the EU. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will," and other words and terms of similar meaning. You should not place undue reliance on these statements. Drug development and commercialization is a lengthy and complex process, which involves a high degree of risk. Factors that could cause actual results to differ materially from our current expectations include: the risk that unexpected concerns may arise from additional data or analysis, or regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our biosimilar drug candidates risks related to our dependence on third parties for the development and commercialization of biosimilars; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; and the risks of other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. These statements are based on our current beliefs and expectations, and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

1 Humira is a registered trademark of AbbVie.
2 Enbrel is a registered trademark of Wyeth LLC.
3 Remicade is a registered trademark of Janssen Biotech, Inc.
i Extrapolated from global sales from Global Data PMLive Top 50 Report.
iiShin D, Kim Y, Kim HS, et al. A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar, And Adalimumab Reference Product (Humira®) in Healthy Subjects. Ann Rheum Dis. 2015; 74 (suppl 2:1265).
iii Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week results) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10).

Contact information

BIOGEN
US MEDIA CONTACT:
Jason Glashow, + 1 781-464-3260
public.affairs@biogen.com
or
EU MEDIA CONTACT:
Shannon Altimari, +41 41 392 1677
publicaffairs.EU@biogen.com
or
INVESTOR CONTACT:
Mike Hencke, +1 781-464-2442
IR@biogen.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

PPG Completes COLORFUL COMMUNITIES Project at Primary School in Kecskemét, Hungary21.8.2017 08:03Pressemelding

PPG (NYSE:PPG) today announced the completion of a COLORFUL COMMUNITIES™ project in Kecskemét, Hungary, that helped revitalize the learning environment of the Corvin Mátyás primary school. The Colorful Communities program provides PPG volunteers and products along with financial contributions to bring color and vitality to communities where the company operates around the world, such as in Kecskemét, where the PPG automotive service team operates with 33 employees. The project brought together more than 140 PPG and community volunteers who spent three days at the school revitalizing four classrooms, four changing rooms and the playground. PPG provided more than $20,000 to assist with the project, including more than 460 liters of Héra ® Prémium waterborne interior paint and Trinát ® Aqua wate

Glennmont Partners Completes Refinancing of Sleaford Biomass Plant for £150m21.8.2017 08:00Pressemelding

Glennmont Partners has successfully completed the refinancing of the Sleaford Renewable Energy Plant on behalf of its dedicated clean energy fund, Glennmont Clean Energy Fund Europe I, as part of a programme of realisations of value from the Fund. Glennmont Partners is one of Europe’s largest fund managers focusing exclusively on investment in clean energy infrastructure. Glennmont raises long-term capital to invest in alternative power generation projects including wind farms, biomass power stations, solar parks and small-scale hydro power plants. The carefully selected, risk managed investments deliver sustained performance and predictable returns over periods of 10 years or more. Sleaford REP is a 40MWe straw-fired biomass plant located in Lincolnshire, UK. The plant has been in operation since 2014 and is being operated by Burmeister & Wain Scandinavian Contractor (BWSC). The

Boehringer Ingelheim: Advancing anticoagulation care with new data at ESC Congress 201721.8.2017 07:08Pressemelding

Boehringer Ingelheim today announced that it will present important new data on the treatment of patients with atrial fibrillation (AF) at the ESC Congress in Barcelona, Spain, 26-30 August 2017. In total, four abstracts have been accepted, investigating different aspects of AF patient treatment. The results of the RE-DUAL PCI™ trial have been selected for one of the Late Breaking Science sessions of the congress. The RE-DUAL PCI™ trial compared dual therapy with triple therapy after percutaneous coronary intervention (PCI) with stent placement in approximately 2,500 adults with atrial fibrillation. Patients were either treated with dabigatran etexilate (Pradaxa®) and a single antiplatelet agent or with the vitamin K antagonist (VKA) warfarin and two antiplatelets. The dabigatran doses investigated in this trial are the same doses which have already demonstrated effective stroke preven

Study Investigates Performance of Masimo PVi® As Part of Goal-Directed Fluid Therapy During Laparoscopic Bariatric Surgery21.8.2017 06:00Pressemelding

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Firat University in Turkey evaluated the performance of Masimo PVi®, a noninvasive and continuous measurement of the dynamic changes in perfusion index (Pi) that occur during respiratory cycles, as the basis of a goal-directed fluid therapy (GDFT) protocol during laparoscopic bariatric surgery on mechanically-ventilated patients.1 In the study, Dr. Demirel and colleagues sought to evaluate whether using GDFT guided by PVi on morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (RYGB) surgery might result in less intravenous fluid use without compromising outcomes. They enrolled 60 patients and divided them randomly into control and GDFT groups. The control group’s fluid levels were managed by standard fluid therapy, using mean arterial pressure (MAP) and

Permasteelisa Group to Join Grandland21.8.2017 04:11Pressemelding

Worldwide leading contractor in engineering, project management, manufacturing and installation of architectural envelopes and interior systems, Permasteelisa Group, will join forces with Grandland Group – a fast growing, Shenzhen-based specialist in design and construction of architectural decoration. The strategic alliance will create the biggest, most comprehensive curtain wall player in the world, with exceptional potential for further growth for both companies. Permasteelisa will remain fully committed to build avant-garde architectures and top end, high-quality projects which have become its trademark. The news comes today after LIXIL Group Corporation (LIXIL Group) (TOKYO: 5938) – a global leader in the housing and building industry – announced that it has decided to sell 100% of shares of Permasteelisa S.p.A., held by its major subsidiary LIXIL Corporation, to Grandland Holding

LIXIL to Sell Permasteelisa to Grandland21.8.2017 03:42Pressemelding

LIXIL Group Corporation (LIXIL Group) (TOKYO:5938), a global leader in the housing and building industry, today announced that it has decided to sell 100% of the shares of Permasteelisa S.p.A (Permasteelisa) held by its major subsidiary LIXIL Corporation to Grandland Holdings Group Limited (Grandland), a leading Chinese architectural design and construction company. The transaction is subject to customary closing conditions and regulatory approvals, including in China, the United States and Russia. Under the terms of the agreement, the base sale price for Permasteelisa is EURO 467 million. As a result of this transaction and the deconsolidation of Permasteelisa from LIXIL Group, LIXIL Group’s revenue for the full fiscal year ending March 2018 is expected to decrease by approximately 170.0 billion yen from the amount announced on May 8, 2017 (by approximately 9.2% of the previously fore

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom