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Retina Anti-VEGF Biosimilars: How to Prepare for the Coming Wave

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Retina Anti-VEGF Biosimilars: How to Prepare for the Coming Wave MAY 2021 Retina Anti-VEGF Biosimilars: How to Prepare for the Coming Wave © 2021 Syneos Health®. All rights reserved. Contents Executive Summary 3 Opportunities and Risks on the Path to Commercialization 4 Anti-VEGF Retinopathy: The Biosimilar Pipeline 5 Portrait of a Biosimilar Shakeup 6 A High Bar for Novel Retinopathy Therapeutics 9 Rheumatoid Arthritis Biosimilars: Lessons and Caveats 10 What Prescribers and Payers Think 11 Retinal Biosimilar Outlook and Scenarios 12 Tiered Introductions in Two Key Markets 12 Conclusion 14 2 Executive Summary Drugs that treat diseases of the retina, such as wet age-related macular degeneration (wet AMD), make up a well-defined category with two prominent brands— Eylea® (aflibercept) and Lucentis® (ranibizumab)— plus off-label use of the cancer treatment Avastin® (bevacizumab). All three molecules inhibit proteins called vascular endothelial growth A coming wave of factors (VEGF), which cause excessive blood-vessel growth. biosimilars in Europe, the Physicians, patients and payers have relatively clear expectations for U.S. and other markets— these products. But a coming wave of biosimilars in Europe, the U.S. as well as a version of and other markets—as well as a version of bevacizumab developed bevacizumab developed and marketed specifically for ophthalmic use—could radically transform the treatment ecosystem. and marketed specifically for ophthalmic use—could Eylea is the current sector leader. Sold by Regeneron and Bayer, radically transform the it will soon face biosimilar competition in major markets. So will Lucentis and Avastin, which are currently second and third in sales, treatment ecosystem. respectively. Together, the three anti-VEGF products have served patients well—but at significant cost to health systems. Biosimilars and ocular bevacizumab* will put downward pressure on pricing, without doubt. Yet the speed of physician uptake in all major markets is a persistent puzzle. It is incumbent on biosimilar companies and brand innovators— as well as physicians and payers—to understand and prepare for the market transition ahead. This white paper will sketch a variety of scenarios based on anticipated launches of leading anti-VEGF biosimilars and ocular bevacizumab, as well as the arrival of novel retina therapeutics over the next three to five years. Examining historical data on biosimilar introductions in other therapeutic areas, we’ll derive lessons valuable to biosimilar companies and brand owners alike. * Avastin (bevacizumab) is an innovative antibody developed for oncology indications and used off label for retinal disease. Bevacizumab molecules are included in this report because they have unique “biosimilar-like” clinical development qualities and because of the anticipated disruptive nature of bevacizumab labeled for ocular use. See page 7 for details. 3 Opportunities and Risks on the Path to Commercialization The arrival of retinal biosimilars presents a host of intertwined opportunities and risks for both market leaders and new entrants. Global demand for the products is enormous and growing as aging populations in key markets increase. AMD, the leading cause of vision loss in individuals 60 and older, is believed to affect nearly 200 million people globally today, and the number could grow to 288 million by 2040.1 As for hitting safety/efficacy targets and clearing regulatory review, the prospects for biosimilars are excellent in most instances. Analyzing data from 108 biosimilar programs in the Biomedtracker database, Swedish biosimilars company Xbrane found the average program entering Phase I trials had a 78 percent chance of winning market authorization.2 This compares to a 10 percent chance for the average novel therapeutic. Stripping out biosimilar programs that fail due to manufacturing issues or simply marketing decisions, the actual odds for success may be greater than 90 percent. But market authorization is the starting gate, not the finish line. What matters more are decisions taken in the critical weeks or months between approval and launch, and the 12-18 months after a product reaches the market. These decisions must be informed by careful analysis of less tangible determinants, such as prescriber psychology and behavior and the evidentiary preferences of payers. Balancing risks and opportunities within defined market scenarios is essential for branded and biosimilar anti-VEGF contenders alike. In both the U.S. and Europe, players must understand how a medicine’s price, availability, reimbursement status, safety and efficacy affect the order in which prescribers recommend a treatment, as well as the relative weight they assign to each factor. Uncertainties include: • How comfortable physicians will feel in prescribing biosimilar ranibizumab or aflibercept, or labeled bevacizumab, assuming safety and efficacy are similar to the originator products • The amount of discounting providers will expect in order to make the switch We make sure important questions • Whether other incentives will be necessary bearing on commercial success if brand originators decide to match the discount get asked, iterated and answered. • To what degree prior authorizations, step therapies and other restrictions come into play When Syneos Health® works with clients in clinical development, our field of view is never confined to milestones, regulatory approval or the moment of launch. Our cross-disciplinary commercial specialists work closely with clinical teams to ensure the most plausible market-altering scenarios are held in view through each stage of development. We make sure important questions bearing on commercial success get asked, iterated and answered. 4 Retina Anti-VEGF Therapy: The Biosimilar Pipeline Molecule Developers Target Market Development Status Eylea Regeneron, Bayer,* Bayer (ex-U.S.)† Global Originator, approved and marketed MYL1701P Viatris, Momenta Pharmaceuticals, Inc,* Phase III for DME recruitment complete (global) (now Johnson & Johnson)† SB15 Samsung Bioepis, Biogen (ex-China),† Global Phase III for wet AMD recruiting (global) AffaMed Therapeutics (China)† ABP938 Amgen Global Phase III for wet AMD recruiting (global) FYB203 Bioeq GmbH, Formycon AG* Global Phase III for wet AMD recruiting (global) SCO411 SamChunDang Pharmaceutical Co., Ltd. Global Phase III for wet AMD recruiting (global) QL-1207 Qilu Pharmaceutical Co., Ltd. China Phase III for wet AMD recruiting (China) N/a CinnaGen Co. Iran Phase III for wet AMD recruiting (Iran) SOK583Al Hexal AG (Sandoz) Global Phase III for wet AMD recruiting (global) ALT-L9 Altos Biologics (Alteogen Inc.), Global Phase I for wet AMD complete (Korea) Kissei Pharmaceutical Co., Ltd. (Japan)* LY09004 Luye Pharma Co., Ltd. China Phase I for wet AMD complete (China) GBS-012 Gene Techno Science, Kishi Kasei Co., Ltd.* Japan Preclinical SCB-420 Clover Biopharmaceuticals Not disclosed Preclinical Lupin’s ranibizumab Lupin Not disclosed Preclinical Lucentis Genentech, Roche (U.S.),† Novartis (ex-U.S.)† Global Originator, approved and marketed Razumab® Intas Pharmaceuticals India Biosimilar, approved and marketed RanizuRel™ Reliance Life Sciences India Biosimilar, approved and marketed SB11 Samsung Bioepis, Biogen (ex-China),† AffaMed Global European MAA for wet AMD accepted for review Therapeutics (China)† FYB201 Bioeq GmbH, Formycon AG,* Coherus Global Phase III for wet AMD complete (global) BioSciences (U.S.)† SJP-01333 / GBS-007 Senju Pharmaceutical, Gene Techno Science,* AsiaPacific Phase III for wet AMD complete (Japan) Ocumension Therapeutics (China, Taiwan)† Xlucane® Xbrane Biopharma AB, STADA Arzneimittel AG,* Global Phase III for wet AMD recruitment complete Bausch + Lomb† (global) Vicentis Zist Daru Danesh Iran Phase III for wet AMD recruitment complete (Iran) Lupin’s ranibizumab Lupin India / Global Phase III complete (India), Phase III ongoing (global) QL-1205 Qilu Pharmaceutical Co., Ltd. Global Phase III recruiting (global) GNR-067 Generium Pharmaceutical Russia Phase III for wet AMD planned (Russia) IDB0062 (biobetter) Ildong Pharmaceutical Not disclosed Preclinical Avastin® Genentech Global Originator, used off label Lumiere® Laboratorio Elea Argentina Biosimilar, approved and marketed Lytenava™ (ONS-5010) Outlook Therapeutics, Syntone Technologies Global Phase III for wet AMD recruitment complete Group Co. Ltd. (China)* (global) 601 Sunshine Guojian Pharmaceutical China Phase I for wet AMD recruiting (China), (Shanghai) Co., Ltd. Phase II for CRVO planned (China) TAB014 TOT Biopharm Co., Lee’s Pharmaceutical* Global Phase I for wet AMD complete (China) JY028 Beijing Eastern Biotech China Phase I for wet AMD recruiting (China) TK001 Jiangsu T-Mab Biopharma Co., Ltd China Phase I for wet AMD recruiting (China) SCT510A SinoCellTech China Phase I/II for wet AMD planned (China) *Development partner. †Commercial partner. DME = diabetic macular edema; MAA = marketing authorization application 5 Phase I Phase II Phase III Approved and marketed Preclinical European MAA Portrait of a Biosimilar Shake-up For years, patients and prescribers in global markets have benefited from effective anti-VEGF treatments for diseases such as wet AMD, DME and diabetic retinopathy. The first blockbuster, Lucentis, was developed by Genentech—later absorbed into Roche—and sold by Novartis outside the U.S. Net sales came to about USD $3.8 billion in 2020. A little later, Regeneron and Bayer co-developed Eylea and have dominated major markets since launch. Eylea, which generated roughly USD $8 billion globally in 2020, gained
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