BIOGEN TO PRESENT NEW SAFETY AND EFFICACY DATA ON BIOSIMILARS AND ESTIMATES 1.8 BILLION EUROS IN SAVINGS FOR THE EUROPEAN HEALTHCARE SYSTEM IN 2019
- Data to be presented at?the European Congress of Rheumatology?(EULAR) 2019 highlight real-world evidence confirming the safety and efficacy of anti-TNF biosimilars and high adherence of patients to treatment?
- Biogen?s three biosimilar treatments ??BENEPALI? (etanercept), FLIXABI? (infliximab) and IMRALDI? (adalimumab) ? are estimated to save the European healthcare system 1.8 billion euros in 2019
- Biogen and its collaboration partner Samsung Bioepis are the first companies in Europe to market biosimilars that reference the three most prescribed anti-TNF biologic treatments, with approximately 145,000 patients currently on treatment1
- [OPO236]?Glintborg et al. ARTIS: Similar one-year treatment retention of originator and biosimilar etanercept. Results of a Nordic collaboration including 1,015 patients with spondyloarthritis?(June 14, 10:15-11:45 CET ? Hall 7A).
- [SAT0134]?Baganz et al. RABBIT: Comparing real-world retention rates in a matched cohort of rheumatoid arthritis patients who either remained on the etanercept originator or switched to a biosimilar?(June 15, 10:30-12:00 CET ? Hall 10).
- [SAT0146]?Haugeberg et al. Drug survival for biosimilar SB4 etanercept in rheumatoid arthritis both etanercept na?ve and non-medical switch patients with etanercept reference drug in a Norwegian out-patient clinic. Preliminary results from a multi-center study?(June 15, 10:30-12:00 CET ? Hall 10).
- [FRI0094]?Haugeberg et al. Long-term drug survival for biosimilar SB4 etanercept in RA, PsA and aSpA patients with a non-medical switch from etanercept reference drug?(June 14, 11:45-13:30 CET ? ?Hall 10).
- FRI0101]?Kiltz et al. Non-medical switching from originator to biosimilar etanercept - no evidence for a relevant nocebo effect ? a retrospective analysis of real-life data.?(June 14, 11:45-13:30 CET ? Hall 10).
- [SAT0141]?Rebecca Davies et al. BSRBR: Frequency and reasons for switching back to biologic originator following initial switch to biologic biosimilar?(June 15, 10:30-12:00 CET? Hall 10).
- [ABSTRACT ONLY]?Ruiz-Arg?ello et al. Validation of a therapeutic drug monitoring test to measure the adalimumab biosimilar SB5 in comparison to the reference adalimumab (ENCORE).
Biogen Safe Harbor This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to the results of certain real-world data; the potential benefits, safety and efficacy of BENEPALI, FLIXABI and IMRALDI; risks and uncertainties associated with drug development and commercialization; the potential of Biogen?s commercial business and pipeline programs, including BENEPALI, FLIXABI and IMRALDI; anticipated benefits and potential of investments, collaborations and business development activities; Biogen?s strategy and plans; potential cost healthcare savings related to biosimilars. These statements may be identified by words such as ?aim,? ?anticipate,? ?believe,? ?could,? ?estimate,? ?expect,? ?forecast,? ?intend,? ?may,? ?plan,? ?potential,? ?possible,? ?will,? ?would? 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 without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional information or further studies; risks of unexpected costs or delays; 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 Biogen?s biosimilar drug candidates; risks related to Biogen?s dependence on third parties for the development and commercialization of biosimilars; unexpected concerns may arise from additional data, analysis or results obtained during clinical trials; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the risks of other unexpected hurdles; failure to protect and enforce Biogen?s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; 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 U.S. Securities and Exchange Commission. These statements are based on Biogen?s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as result of new information, future developments or otherwise. Contact: BIOGEN GLOBAL MEDIA CONTACT: David CAOUETTE +1 617 679 4945 public.affairs@biogen.com BIOGEN EU MEDIA CONTACT: Marc BURI +41 79 944 9064 marc.buri@biogen.com BIOGEN INVESTOR CONTACT: Mike HENCKE +1 781 464 2442 IR@biogen.com References: 1. Biogen data on file. 2. Kruger et al. BENEFIT Study: A Pan-European Observational Study to Evaluate Real-world Effectiveness of SB4 Following Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis (RA) or Axial Spondyloarthritis (AxSpA). EULAR 2019. 3. Smolen et al. A pooled analysis of 1-year clinical outcome by 6-month disease activity from three TNF inhibitor biosimilar studies in patients with rheumatoid arthritis. EULAR 2019. 4. Data from Biogen- and Samsung Bioepis- supported studies. 5. Enbrel??is a registered trademark of Wyeth LLC. 6. Data on File: IQVIA, GERS, Insight Health ODV 7. Remicade??is a registered trademark of Janssen Biotech, Inc. 8. Data on File: IQVIA, GERS, Insight Health ODV 9. Humira??is a registered trademark of AbbVie Biotechnology Ltd. 10. Data on File: IQVIA, GERS, Insight Health ODV 11. Data on File: Biogen, Inc. Q1 First Quarter 2019 Financial Results and Business Update. April 24th, 2019.