TMCnet News
Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab)INCHEON, South Korea and CAMBRIDGE, Mass., Oct. 06, 2020 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. If approved, SB11 will join a growing number of biosimilars developed by Samsung Bioepis and commercialized by Biogen. “The EMA filing acceptance for SB11 (ranibizumab) further demonstrates the productive collaboration between Samsung Bioepis and Biogen and brings us closer to our shared goal of offering new affordable treatment options for people with retinal vascular disorders,” said Hee Kyung Kim, Senior Vice President, Clinical Sciences and Regulatory Affairs Division Lead at Samsung Bioepis. “We believe SB11 has the potential to be a meaningful new offering for patients with retinal vascular disorders, and we look forward to continued engagement with the EMA throughout the review process.” “The EMA acceptance of the SB11 (ranibizumab) application is an important step as we work to bring a new potential treatment option for patients with retinal vascular disorders and would represent a significant addition to our biosimilar portfolio,” said Ian Henshaw, Senior Vice President and Global Head of Biosimilars at Biogen. “We believe our biosimilar offerings are essential as we collaborate with payers and health authorities globally with the goal of creating budget headroom to fund innovation and ensure sustainable healthcare systems.” Samsung Bioepis announced in November 2019 that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (U.S.), Canada, Europe, Japan and Australia. About Samsung Bioepis Co., Ltd. About Biogn We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit http://www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube. Safe Harbor These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, actual timing and content of submissions to and decisions made by the regulatory authorities regarding SB11; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of SB11; risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the development and potential commercialization of SB11, 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 SB11 and other unexpected difficulties or hurdles; the occurrence of adverse safety events; unexpected concerns that may arise from additional data or analysis; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition; the risks of doing business internationally, including currency exchange rate fluctuations; 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 a result of new information, future developments or otherwise. Media Contact - Samsung Bioepis [EU news release] Yoon Kim: +82-31-8061-1783, [email protected] [US news release] Anna Nayun Kim: +82-31-8061-1604, [email protected] Media Contact - Biogen For Investors: Joe Mara, +1 781 464 2442, [email protected] For Media: David Caouette, +1 617 679 4945, [email protected] |