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INCHEON, Korea and CAMBRIDGE, Mass., June 25, 2021 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) at the moment introduced that the European Medicines Company’s (EMA) Committee for Medicinal Merchandise for Human Use (CHMP) has adopted a constructive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®1 (ranibizumab), also called SB11. Ranibizumab is an anti-VEGF (vascular endothelial development issue) for retinal vascular problems, that are a number one reason behind blindness. BYOOVIZ has been really useful for approval for the therapy of neovascular (moist) age-related macular degeneration (AMD), visible impairment because of diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visible impairment because of macular odemea secondary to retinal vein occlusion (department RVO or central RVO) and visible impairment because of choroidal neovascularization (CNV) within the European Union (EU).
The CHMP’s constructive opinion will now be referred to the European Fee (EC), which can resolve whether or not to grant a advertising and marketing authorization for BYOOVIZ. If a advertising and marketing authorization is granted by the EC, BYOOVIZ could be added to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, together with three broadly prescribed anti-TNF biosimilars in Europe: BENEPALI™, IMRALDI™ and FLIXABI™.
“We’re very proud to see BYOOVIZ changing into the primary biosimilar of ranibizumab to be really useful for approval in Europe. This marks an necessary milestone for our firm, as that is one step ahead to increasing affected person entry to remedies for retinal vascular problems,” mentioned Kyung-Ah Kim, Senior Vice President and Growth Division at Samsung Bioepis. “We are going to proceed our efforts to develop and ship high-quality and confirmed biologic medicines to extra sufferers and healthcare techniques in Europe.”
“Retinal vascular problems have an effect on tens of millions of individuals, and we imagine BYOOVIZ has the potential to be a significant therapeutic providing for sufferers dwelling with these problems,” mentioned Ian Henshaw, World Head of Biosimilars at Biogen. “Biosimilars might assist broaden entry and supply important healthcare financial savings via the therapy of those complicated and sometimes debilitating ophthalmic ailments.”
This constructive CHMP opinion on BYOOVIZ was based mostly on a Part 3 medical research that demonstrated equivalence in efficacy for each major endpoints. The adjusted therapy variations between teams have been inside predefined equivalence margins for imply adjustments from baseline in each finest corrected visible acuity (BCVA) and in central subfield thickness (CST). The enhancements within the major efficacy outcomes remained steady and appeared comparable between therapy teams in any respect time factors as much as week 52.
In November 2019, Samsung Bioepis and Biogen introduced that they’d entered right into a commercialization settlement for 2 ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and SB15 (aflibercept), within the U.S., Canada, Europe, Japan and Australia.
Moreover, the Biologics License Software for SB11 was accepted for assessment by the U.S. Meals and Drug Administration in November 2020.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical firm dedicated to realizing healthcare that’s accessible to everybody. By way of improvements in product improvement and a agency dedication to high quality, Samsung Bioepis goals to grow to be the world’s main biopharmaceutical firm. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cowl a spectrum of therapeutic areas, together with immunology, oncology, ophthalmology, hematology and endocrinology. Samsung Bioepis is a three way partnership between Samsung Biologics and Biogen. For extra info, please go to: www.samsungbioepis.com and observe us on social media – Twitter, LinkedIn.
About Biogen
At Biogen, our mission is evident: we’re pioneers in neuroscience. Biogen discovers, develops and delivers worldwide progressive therapies for folks dwelling with critical neurological and neurodegenerative ailments in addition to associated therapeutic adjacencies. One of many world’s first international biotechnology firms, Biogen was based in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. At the moment Biogen has the main portfolio of medicines to deal with a number of sclerosis, has launched the primary accredited therapy for spinal muscular atrophy, commercializes biosimilars of superior biologics and is targeted on advancing analysis applications in a number of sclerosis and neuroimmunology, Alzheimer’s illness and dementia, neuromuscular problems, motion problems, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic ache.
We routinely publish info that could be necessary to traders on our web site at www.biogen.com. To be taught extra, please go to www.biogen.com and observe us on social media – Twitter, LinkedIn, Facebook, YouTube.
Secure Harbor
This information launch comprises forward-looking statements, together with statements made pursuant to the secure harbor provisions of the Non-public Securities Litigation Reform Act of 1995, referring to the potential advantages, security and efficacy of SB11; the timing and standing of present and future regulatory filings; dangers and uncertainties related to drug improvement and commercialization, together with SB11; the potential of Biogen’s business enterprise and pipeline applications, together with BENEPALI, IMRALDI, FLIXABI and SB11; the anticipated advantages and potential of Biogen’s collaboration preparations with Samsung Bioepis; Biogen’s technique and plans; and potential price healthcare financial savings associated to biosimilars. These forward-looking statements could also be accompanied by phrases comparable to “purpose,” “anticipate,” “imagine,” “might,” “estimate,” “anticipate,” “forecast,” “intend,” “might,” “plan,” “potential,” “doable,” “will,” “would” and different phrases and phrases of comparable which means. Drug improvement and commercialization contain a excessive diploma of threat, and solely a small variety of analysis and improvement applications end in commercialization of a product. Leads to early stage medical trials might not be indicative of full outcomes or outcomes from later stage or bigger scale medical trials and don’t guarantee regulatory approval. You shouldn’t place undue reliance on these statements or the scientific knowledge offered.
These statements contain dangers and uncertainties that would trigger precise outcomes to vary materially from these mirrored in such statements, together with with out limitation, precise timing and content material of submissions to and choices made by the regulatory authorities concerning SB11; regulatory submissions might take longer or be harder to finish than anticipated; regulatory authorities might require further info or additional research, or might fail or refuse to approve or might delay approval of SB11; dangers of surprising prices or delays or different surprising hurdles; uncertainty of success within the improvement and potential commercialization of SB11, which can be impacted by, amongst different issues, the extent of preparedness of healthcare suppliers to deal with sufferers, difficulties in acquiring or adjustments within the availability of reimbursement for SB11 and different surprising difficulties or hurdles; the prevalence of adversarial security occasions; surprising issues that will come up from further knowledge or evaluation; failure to guard and implement knowledge, mental property and different proprietary rights and uncertainties referring to mental property claims and challenges; dangers of authorized actions, regulatory scrutiny or different challenges to biosimilars; the direct and oblique impacts of the continued COVID-19 pandemic on Biogen’s enterprise, outcomes of operations and monetary situation; product legal responsibility claims; and third celebration collaboration dangers. The foregoing units forth many, however not all, of the elements that would trigger precise outcomes to vary from Biogen’s expectations in any forward-looking assertion. Traders ought to think about this cautionary assertion in addition to the chance elements recognized in Biogen’s most up-to-date annual or quarterly report and in different experiences Biogen has filed with the U.S. Securities and Change Fee. These statements are based mostly on Biogen’s present beliefs and expectations and communicate solely as of the date of this information launch. Biogen doesn’t undertake any obligation to publicly replace any forward-looking statements, whether or not on account of new info, future developments or in any other case.
References:
1Lucentis is a registered trademark of Genentech, Inc.
Media Contact – Samsung Bioepis
[EU news release] Yoon Kim: +82-31-8061-1783, yoon1.kim@samsung.com
[US news release] Anna Nayun Kim: 82+31-8061-1604, nayun86.kim@samsung.com
Media Contact – Biogen
For Traders: Mike Hencke, +1 781 464-2442, IR@biogen.com
For Media: Allison Parks, +1 781 464-3260, public.affairs@biogen.com
