Apremilast

MEDIA RELEASE Pyzchiva® first ustekinumab biosimilar in Europe commercially available in pre-filled pen (autoinjector), offering improved self-administration experience for better treatment adherence and quality of life [1-10] Autoinjector includes unique features to improve comfort, independence and convenience for patients with chronic inflammatory diseases [1-10] Launch strengthens Sandoz biosimilar leadership position in immunology and commitment to patient-centric innovation Basel, May 21, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced the European launch of its Pyzchiva®* (ustekinumab) autoinjector.[1-2] This is the first ustekinumab biosimilar in Europe commercially available in an autoinjector. Developed and registered by Samsung Bioepis, Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients aged six years and older, weighing over 60 kg.[1] The Pyzchiva® autoinjector supports a more comfortable self-administration experience [1-10] with accurate automatic dosing [1,3,4], less frequent injection pain [1,9,10], a compact design [1,3,4,6,7], and flexible storage options [1], offering the potential for improved adherence to patient treatment plans. Christophe Delenta, President Europe, Sandoz, said: “Access to medicine does not end when it reaches the hands of the patient. The Pyzchiva® autoinjector, with its thoughtful and advanced features, addresses the real-world needs of patients in managing chronic inflammatory diseases. This launch marks another important milestone as we strengthen our leadership in immunology biosimilars and reaffirm our commitment to pioneering access across Europe’s evolving healthcare landscape.” Europe has the highest prevalence of psoriasis worldwide, affecting an estimated 6.4 million people.[11-13] Inflammatory bowel diseases, such as Crohn’s disease, are also common in Europe, affecting an estimated 2.5 to 3 million people.[14] Non-adherence to biologic therapies can lead to disease progression, increased flares and reduced quality of life, while contributing to increased healthcare utilization, including hospitalizations and additional treatments, thereby escalating healthcare costs.[15,16] Pyzchiva® is a key biosimilar value driver for the Sandoz growth strategy. It has been launched in 23 markets in Europe. The autoinjector is now available in Spain and will continue to roll out across Europe. Sandoz entered into a development and commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva® in Brazil, the US, the European Economic Area (EEA), Switzerland and the UK. Samsung Bioepis remains responsible for development, registration, intellectual property, manufacturing and supply. ABOUT PYZCHIVA® (USTEKINUMAB) Pyzchiva® (ustekinumab) has been developed as a biosimilar with equivalent efficacy and comparable safety to the reference medicine Stelara®**, a human monoclonal antibody against interleukin (IL)-12/23. Pyzchiva® is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six years and older weighing over 60 kg. The Pyzchiva® autoinjector is a pre-filled pen delivered through the Molly®*** platform of SHL Medical AG. It is available as a 90 mg in 1 mL autoinjector or a 45 mg in 0.5 mL autoinjector.[1,2] Pyzchiva® is also available as a 130mg concentrate in a vial for solution for infusion, a 90 mg and a 45 mg concentrate solution for injection in a pre-filled syringe. *Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd. **Stelara® is a trademark of Johnson & Johnson ***Pyzchiva® will be delivered by SHL Medical’s patented Molly® technology. Molly® is a registered trademark of SHL Medical AG DISCLAIMER This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES [1] Pyzchiva® (ustekinumab) Summary of Product Characteristics. Available at: ema.europa.eu/en/documents/product-information/pyzchiva-epar-product-information_en.pdf (Accessed May 2025). [2] Samsung Bioepis. Data on file. [3] SHL Medical AG. Molly® autoinjector white paper. Available at: shl-medical.com/news-insights/downloads (Accessed May 2025). [4] SHL Medical AG. Molly® SE autoinjector letter. April 16, 2025. Data on file. [5] Paul C, Stalder JF, Thaçi D, et al. Patient satisfaction with injection devices: a randomized controlled study comparing two different etanercept delivery systems in moderate to severe psoriasis. J Eur Acad Dermatol Venereol . 2012;26:448–455. [6] Tischer B, Mehl A. Patients’ and nurses’ preferences for autoinjectors for rheumatoid arthritis: results of a European survey. Patient Prefer Adherence . 2018;12:1413–1424. [7] Thakur K, Sandhu SK, Sharma A. Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe. Rheumatol Ther . 2016;3:245–256. [8] Lopez A, Mounier M, Bouvier AM, et al.Adherence to anti-TNF therapy in inflammatory bowel diseases: a systematic review. Inflamm Bowel Dis . 2013;19:1528–1533. [9] Arendt-Nielsen L, Petersen-Felix S, Fischer M, Bak P. Pain following controlled cutaneous insertion of needles with different diameters. Somatosens Mot Res . 2006;23:37–43. [10] Gill HS, Prausnitz MR. Does needle size matter? J Diabetes Sci Technol . 2007;1:725–729. [11] International Federation of Psoriasis Associations (IFPA). Speaking up for psoriatic disease in Europe. Available at: ifpa-pso.com/content/tools/20072022_IFPA-FORUM_Briefing-Book_Speaking-up.pdf (Accessed May 2025). [12] Frede N, Gerdes S, Schön MP, et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: a cross-sectional study of 300 patients. Rheumatol Ther . 2023;10:1655–1668. [13] Palfreeman AC, McNamee KE, McCann FE. New developments in the management of psoriasis and psoriatic arthritis: a focus on apremilast. Drug Des Devel Ther . 2013;7:201–210. [14] Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis . 2013;7:322–337. [15] Vangeli E, Bakhshi S, Baker A, et al. A systematic review of factors associated with non-adherence to treatment for immune-mediated inflammatory diseases. Adv Ther . 2015;32:983–1028. [16] Maniadakis N, Toth E, Schiff M, et al. A targeted literature review examining biologic therapy compliance and persistence in chronic inflammatory diseases. Adv Ther . 2018;35:1333–1355. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. CONTACTS Global Media Relations Investor Relations Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alex Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Joerg E. Allgaeuer +49 171 838 4838 Rupreet Sandhu +41 79 410 5472 Attachment Media release_Pyzchiva autoinjector European launch.pdf Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

近日，美国特拉华州地区法院的陪审团裁定，安进在其降脂药物Repatha的销售推广中违反了反垄断法和侵权法，判定其向其竞争对手再生元支付总计4.068亿美元的损害赔偿。围绕期各自开发的PCSK9单抗Praluent和Repatha，两家公司的恩怨已经由来已久。2003年，PCSK9被发现第三个与高胆固醇血症有关的基因，通过研究进一步发现该基因功能获得性或丧失性突变可以导致低密度脂蛋白（LDL）水平明显升高或降低。2007年，来自安进公司团队首次解析了PCSK9的晶体结构，并通过实验证实PCSK9是通过与LDL-R的紧密结合发挥作用的。有鉴于安进公司团队在PCSK9研究上的研究成果，在Praluent和Repatha上市前，两家公司便打起了专利战。2014年，安进起诉了再生元以及合作伙伴赛诺菲，指控Praluent侵犯了Repatha的专利，双方最终一直对峙到美国最高法院，直到2023年这项旷日持久的的专利诉讼以安进的败诉而告终。专利战之外，两款药物在上市伊始就是争锋相对的竞争关系。Praluent和Repatha在同一年获批上市，前后时间也就相差一个月（分别是2015年7月和8月）。降脂效果上，两款PCSK9单抗也不相上下，降低LDL-C水平分别为47%和48.8%。刚推出时，Repatha和Praluent定价也相当，分别为14523美元/年和14300美元/年。后面为了扩大市场渗透率，两家公司最终也都进行了大幅降价，安进在2018年10月率先降价60%，Repatha至5850美元。赛诺菲/再生元也在2019年3月开始降价，同样降至5850美元/年。药效不相上下、药价相同、但是Repatha和Praluent的销售额却有不小的差距，晚了一个月上市的Repatha始终卖的比Praluent好，2024年，Praluent的销售额还不及Repatha的一半多。而在再生元看来，安进一直销售额方面实现领先与其采取的捆绑销售息息相关。在2022年5月，再生元对安进提起了诉讼，指控其采取的Repatha捆绑销售行为违反了反垄断法。具体而言，安进通过利用将Repatha与另外两款畅销药Otezla和Enbrel捆绑在一起销售，促使PBM更倾向于（不得不）选择Repatha。安进还进一步威胁PBM称，如果其不优先选择Repatha且将排除Praluent在处方之外，其将扣留回扣。陪审团认为，安进通过威胁扣留回扣，阻止了再生元在公平的竞争环境中竞争，并且还阻碍了患者获得Praluent治疗的机会。最终陪审团判决安进向再生元支付1.356亿美元的补偿性损害赔偿和2.712亿美元的惩罚性损害赔偿。参考出处https://investor.regeneron.com/news-releases/news-release-details/regeneron-prevails-over-amgen-antitrust-pcsk9-lawsuit-protectinghttps://www.fiercepharma.com/pharma/amgen-hook-pay-more-400m-after-regeneron-triumphs-cholesterol-drug-antitrust-suithttps://firstwordpharma.com/story/5962117本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处········