Biogen’s IMRALDI®, an Adalimumab Biosimilar Candidate Referencing Humira®, Granted Positive Opinion by Committee for Medicinal Products for Human Use
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for IMRALDI® (also known as SB5), an adalimumab biosimilar candidate referencing Humira®.1 The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). IMRALDI marks the third anti-TNF candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.
If approved by the EC, IMRALDI would be approved for the treatment of rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, polyarticular juvenile idiopathic arthritis, active enthesitis-related arthritis, hidradenitis suppurativa and non-infectious uveitis.
Today, the anti-TNF market alone accounts for an estimated $9 billion of healthcare expenditures in Europe,2 of which Humira accounts for $4 billion.2 Global sales estimates for Humira stand at $16 billion in 2017, making it the number-one prescribed biologic therapy in the world.3 Earlier this year, data were unveiled at the ISPOR 22nd Annual Meeting in Boston showing that biosimilar introduction of the top-three anti-TNF therapies in Europe could result in savings of $11.44 billion by 2020.4 Of these savings, $3.18 billion could be attributed to prescribing an adalimumab biosimilar referencing Humira, despite only being approved near the end of the study period.4
“If IMRALDI receives approval, Biogen will be the first company to have approved biosimilars of the three most prescribed anti-TNF biologic treatments in Europe,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “This portfolio expansion is in line with our mission to increase access to biologics that have transformed the treatment of chronic autoimmune conditions like rheumatoid arthritis. Being able to provide this range of anti-TNF treatment alternatives bolsters our leadership position and underscores our commitment to expanding physician choice, while supporting the sustainability of healthcare systems.”
The positive opinion is based on a robust preclinical and clinical data package comparing IMRALDI 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 Humira5 and a Phase III, randomized, double-blind, multicenter study, in which IMRALDI demonstrated equivalent efficacy and comparable safety and immunogenicity to Humira in patients with RA.6 The primary endpoint of the Phase III study, the American College of Rheumatology 20% (ACR20) response at Week 24, was met, demonstrating equivalent efficacy to Humira.6 Secondary endpoints demonstrated that IMRALDI has a comparable safety and immunogenicity profile to Humira.6
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
Biogen Safe Harbor
This press release includes forward-looking statements, including statements about the potential indications for IMRALDI, and the potential approval of IMRALDI 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 Extrapolated from global sales from Global Data PMLive Top 50 Report.
3 Gibney M. FiercePharma special report: The top 20 drugs in 2020 – worldwide sales (1. Humira).
4 Psachoulia et al. Potential impact of the biosimilars introduction of 3 anti-TNFs in the European market. Value Health 2017, May; 20(5); A143.
5 Shin 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).
6 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).
Om Business Wire
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
The Brightline Initiative, Project Management Institute and The Boston Consulting Group Host The Economist Events for Davos Panel19.1.2018 21:13 | Pressemelding
The Brightline™ Initiative, a non-commercial coalition dedicated to helping organizations bridge the gap between strategy design and strategy delivery, along with Project Management Institute (PMI) and The Boston Consulting Group are hosting The Economist Events on the panel discussion, “The Business Case for Openness: Implementing Strategy in a Drawbridge up World.” This event marks Brightline’s debut at Davos. Dovetailing with the World Economic Forum’s overarching theme, “Creating a Shared Future in a Fractured World,” the discussion will address how business leaders can better adapt and implement strategies to promote openness and collaboration. PMI, a founding coalition member of Brightline, is particularly passionate about this topic, given the fact that they focus on collaborating with world-leading organizations to improve infrastructure initiatives in developing and mature communities around the world. “Today the challenges to sustainable growth through strategy implementation
New US Patent for Solidia Technologies’ CO2-cured Concrete Advances Performance and Sustainability of Building Materials19.1.2018 18:07 | Pressemelding
The U.S. Patent and Trademark Office issued a patent for the structure of CO2-cured Solidia Concrete™, advancing the performance and sustainability of materials available to the global construction and materials industries. Solidia Technologies® holds the exclusive licensing rights to the patent, which is held by Rutgers University, where the original generation of the material was invented. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005608/en/ Solidia Concrete™ pavers. (Photo: Business Wire) U.S. Patent No. 9,868,667, "Bonding Element, Bonding Matrix and Composite Material Having the Bonding Element and Method of Manufacturing Thereof," covers the composition of matter of the non-hydraulic concrete. “The hydrate bonds in conventional concrete can compromise that material’s strength and durability,” explained Solidia Chief Technology Officer Nicholas DeCristofaro, Ph.D. “With CO2-cured concrete, bonding elements bas
Schlumberger Announces Full-Year and Fourth-Quarter 2017 Results19.1.2018 12:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for full-year 2017 and the fourth quarter of 2017. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2017 Dec. 31, 2016 Year-on-year Revenue $30,440 $27,810 9% Pretax operating income $3,921 $3,273 20% Pretax operating margin 12.9% 11.8% 111 bps Net loss (GAAP basis) $(1,505) $(1,687) n/m Net income, excluding charges and credits* $2,085 $1,550 35% Diluted EPS (loss per share) (GAAP basis) $(1.08) $(1.24) n/m Diluted EPS, excluding charges and credits* $1.50 $1.14 32% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Full-year 2017 revenue of $30.4 billion increased 9% year-on-year. This included a full year’s activity from the acquired Cameron businesses as compared to three quarters of activity in 2016. Excluding the addition of Cameron, revenue growth was driven by land activity in North America, which increa
The Coca-Cola Company Announces New Global Vision to Help Create a World Without Waste19.1.2018 11:55 | Pressemelding
The Coca-Cola Company announced today that it is fundamentally reshaping its approach to packaging, with a global goal to help collect and recycle the equivalent of 100% of its packaging by 2030. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005104/en/ In 2017, employees from Heartland Coca-Cola Bottling Co. joined with other volunteers in St. Louis to collect and sort 14,480 pounds of debris; 63 percent was diverted for recycling. Coca-Cola then partnered with manufacturer Phoenix Technologies to convert plastic bottles into recycled PET plastic for use in new bottles. (Photo: Business Wire) This goal is the centerpiece of the Company’s new packaging vision for a World Without Waste, which the Coca-Cola system intends to back with a multi-year investment that includes ongoing work to make packaging 100% recyclable. This begins with the understanding that food and beverage containers are an important part of people’s m
Researchers and Scientists from Five Countries Named Winners of King Faisal Prize 201819.1.2018 10:33 | Pressemelding
Five researchers and scientists from Malaysia, Jordan, Tunisia, the US and the UK have been named winners of the King Faisal Prize 2018 as the 40th edition of the renowned award recognized their distinguished contributions towards humanity. The Prize honours exceptional achievements in five categories: Service to Islam, Islamic Studies, Arabic Language & Literature, Medicine, and Science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005245/en/ His Royal Highness Prince Khalid Al-Faisal, Chairman of King Faisal Prize Board, Abdulaziz (Photo: AETOSWire) Professor Irwandi Jaswir, Deputy Dean of the International Institute for Halal Research and Training (INHART) and Secretary of Council of Professors at the International Islamic University Malaysia (IIUM), has been named the winner in the Service to Islam category for contributions to the development of ‘Halal Science’ and Halal food and consumer goods. Professor Bashar
E.ON Chooses Corinex Broadband over Powerline Technology for their Smart Metering Rollout19.1.2018 06:00 | Pressemelding
E.ON, an international energy company that serves 32 million customers across multiple countries, has decided to use broadband over powerline (BPL) as the key technology in their communication mix, in the smart metering communication infrastructure for the low voltage part of their grid. E.ON chose Corinex as the solution provider for the initial two years of the deployment. The initial deployment will be several ten thousands of repeaters and head ends providing secure communication for a couple of hundred thousands of households. Corinex Grid Value network management based on IBM Tivoli platform will manage the network. “After extensive field trials, we found that Corinex broadband over powerline technology meets our requirements for mass rollout of smart metering services. We are convinced BPL is ideally suited to address the needs of many other utilities, so E.ON is interested in supporting BPL industry standardization in order to create a broad ecosystem of silicon and system vend
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom