IMRALDI, Biogen?s Adalimumab Biosimilar Referencing Humira, Is Launched in the European Union
- IMRALDI is approved in the European Union for the same 14 complex autoimmune conditions as its reference product
- In 2017 Biogen became the first company in Europe with approved biosimilars referencing the three most prescribed anti-TNF biologic treatments
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 and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
Biogen Safe Harbor This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of IMRALDI; the results of certain Phase I and Phase III studies of IMRALDI; the potential of Biogen?s commercial business, including IMRALDI, BENEPALI and FLIXABI; and risks and uncertainties associated with drug development and commercialization, including the commercialization of IMRALDI. These statements may be identified by words such as ?aim,? ?anticipate,? ?believe,? ?could,? ?estimate,? ?expect,? ?forecast,? ?goal,? ?intend,? ?may,? ?plan,? ?possible,? ?potential,? ?will? and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in commercialization of IMRALDI, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for IMRALDI, the effectiveness of sales and marketing efforts and problems with the manufacturing process for IMRALDI; 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, including IMRALDI; the occurrence of adverse safety events; failure to obtain regulatory approvals in other jurisdictions; failure to protect intellectual property and other proprietary rights; product liability claims; and third party collaboration risks.? The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen?s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen?s most recent annual or quarterly report and in other reports Biogen has filed with the Securities and Exchange Commission. These statements are based on Biogen?s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments, or otherwise. Contact: BIOGEN MEDIA CONTACT: David Caouette +1 617 679 4945 david.caouette@biogen.com BIOGEN INVESTOR CONTACT: Matt Calistri +1 617 679 3342 matt.calistri@biogen.com Samsung Bioepis MEDIA CONTACT: Andrew Ward/Ben Atwell +44 20 3727 1000 samsungbioepisUK@fticonsulting.com ____________________________ 1 Humira??is a registered trademark of AbbVie Biotechnology Ltd. 2 Enbrel??is a registered trademark of Wyeth LLC. 3 Remicade??is a registered trademark of Janssen Biotech, Inc. 4 Extrapolated from global sales from Global Data PMLive Top 50 report, available at:?http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical_products_by_global_sales. Accessed October 2018 5 Currency exchange rates (rounded). Available at:?www.xe.com. Accessed October 2018. 6 Psachoulia E, et al. 2017 Value Health;20(5):A143 7 Biogen website. www.Biogen.com. Last accessed 8th October 2018 8 Delivering on the Potential of Biosimilar Medicines. Report by the IMS Institute of Healthcare Informatics. March 2016 9 Shin D, 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. 10 Weinblatt M, 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). 11 Weinblatt M, et al. FRI0161 Sustained Efficacy and Comparable Safety and Immunogenicity after Transition To SB5 (An Adalimumab Biosimilar) vs Continuation of The Adalimumab Reference Product in Patients with Rheumatoid Arthritis: Result of Phase III Study. Annals of the Rheumatic Diseases 2016;75:487.