Infliximab-ABDA

The amended agreement deepens Organon and Samsung Bioepis’s collaboration to six biosimilars in Canada across multiple therapeutic areas, including immunology, oncology and dermatology. To be launched in Canada in 2026 INCHEON, South Korea & KIRKLAND, Quebec--(BUSINESS WIRE)--Samsung Bioepis and Organon, a global healthcare company with a deep expertise in biosimilars, announced the expansion of their development and commercialization agreement, whereby Organon will obtain commercialization rights in Canada to PYZCHIVA ® , Samsung Bioepis’s biosimilar referencing STELARA ® (ustekinumab). PYZCHIVA ® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids, moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Under the terms of the agreement, Organon will obtain exclusive commercial rights to the product in Canada while Samsung Bioepis will maintain full development, manufacturing, and regulatory responsibilities. This agreement expands the biosimilar portfolio under Organon and Samsung Bioepis’s collaboration in Canada from five to six complementary products. The five other products in the collaboration in Canada are HADLIMA ® (adalimumab), BRENZYS ® (etanercept), RENFLEXIS ® (infliximab), AYBINTIO ® (bevacizumab), and ONTRUZANT ® (trastuzumab). PYZCHIVA ® is expected to be launched in the market in 2026. "In Canada, biosimilars have played a significant role in strengthening the financial stability of the healthcare systems by reducing medical expenditure for the governments, hospitals, and patients. Samsung Bioepis is proud to have contributed to making biologic medicines more affordable for all stakeholders. By expanding our commercial partnership with Organon, we hope to create greater synergy in accelerating access to our biologic medicines,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, Samsung Bioepis. “We will work relentlessly to ensure continued supply of our ustekinumab biosimilar to patients in the Canadian market.” “We’re proud to strengthen our longstanding relationship with Samsung Bioepis one of Organon’s key global collaborators as we continue to work to help expand access to medicines and advance a more sustainable healthcare system,” said Dominic Bégin, President and Managing Director, Organon Canada. “In Canada, we have built a strong foundation in delivering accessible biosimilars for patients, as demonstrated over the past ten years. By leveraging our capabilities and expertise, we see opportunity to expand access to this treatment, helping more patients receive the care they need while providing an important alternative option that supports both healthcare providers and the broader system.” With the addition of PYZCHIVA ® to the Samsung Bioepis and Organon portfolio, the companies reinforce their commitment to delivering more treatment options that can help reduce spending pressures on healthcare systems and expand access to medicines for patients. An estimated 1 in 140 Canadians lives with Crohn’s or colitis, the two main forms of inflammatory bowel disease (IBD), which cause inflammation of the intestines. i Also, it is estimated that one million Canadians are currently living with psoriasis, a chronic inflammatory skin condition that causes red to violet elevated areas of skin (plaques), usually covered with silvery-white scales that can be itchy and painful. Up to 30% of patients with psoriasis have associated psoriatic arthritis. ii For more information about PYZCHIVA ® (ustekinumab) in Canada, including important safety information, visit . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit and follow us on LinkedIn and X . About Organon Organon is an independent global healthcare company dedicated to improving the health of women throughout their lives. With a diverse portfolio of over 70 medicines and products in women’s health, biosimilars, and general medicines across a range of therapeutic areas, Organon is committed to innovation and collaboration. Headquartered in Jersey City, New Jersey, with a Canadian office in Kirkland, Quebec, Organon has approximately 10,000 employees worldwide. For more information, visit and connect with us on LinkedIn . Cautionary Note Regarding Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States’ Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about PYZCHIVA ® for the treatment of adult patients with chronic moderate to severe plaque psoriasis and other conditions, as well as statements regarding the expanded commercial launch of that product and other biosimilars in Canada pursuant to the development and commercialization agreement. Forward-looking statements may be identified by words such as “will,” “expected,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site ( ). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. STELARA ® is a trademark registered in Canada in the name of Johnson & Johnson. Organon is not associated with this trademark owner. i Crohn’s and Colitis Canada. Resources and Publications. Available at: . Accessed on June 12, 2026. ii Canadian Dermatology Association. Psoriasis. Available at: . Accessed on June 12, 2026. Contacts Organon Canada Media Contact: media_canada@organon.com Organon Investor Relations: Jennifer Halchak (201) 275-2711 Samsung Bioepis Media Contacts: Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

合作机会来了！ 国内上市药企寻找临床阶段妇科（肿瘤除外）或抗感染创新药，小分子优先。希望成熟靶点，风险低。 欢迎感兴趣的药企立即联系药时代BD团队！ BD@drugtimes.cn 2026年4月27日，印度太阳制药（Sun Pharmaceutical）与欧加隆（Organon）联合宣布，双方已签署最终收购协议。太阳制药将以每股14美元、总价117.5亿美元（约合人民币802亿元）收购这家从默沙东分拆出来的女性健康巨头。交易已获双方董事会批准，预计将于2027年初正式完成，届时欧加隆将成为太阳制药的全资子公司。 这桩交易不仅是印度药企史上最大规模的海外并购，也悄然改写了全球制药业的竞争版图。合并后，双方年营收合计将达约124亿美元，业务覆盖150个国家，一跃跻身全球制药企业前25强。 然而，在这场资本盛宴的表象之下，两家企业截然不同的身世轨迹与同样急迫的战略焦虑，决定了这场收购绝非一次轻松的握手。 2021年，当欧加隆作为独立公司登上纽交所时，其女性健康、生物类似药、成熟品牌药三大板块让投资者有理由相信，一家在全球范围内深耕百年、拥有60余种成熟药物的公司，市值至少应在百亿美元级别。 然而五年后，欧加隆的股价已较上市初期缩水超过81%，市值一度跌至约25亿美元。反观太阳制药，这家1983年以800美元草根起家的印度仿制药企，一路通过并购滚雪球般构建起约480亿美元的庞大帝国，市值足足是欧加隆的19倍。 据《制药经理人杂志》数据，两家公司2024年处方药年营收均约60亿美元，分列全球第30、31位。同等体量的营收面前，资本市场给出了截然不同的定价。这差出的19倍，正是仿制药的规模红利与专利悬崖下品牌药困境之间的一道鸿沟。 117.5亿美元的交易盘子很有说法。根据协议，太阳制药以约34亿美元收购欧加隆全部股权，同时整体接下后者约86亿美元的债务。太阳制药账上自有现金约32亿美元，剩余约92.5亿至97.5亿美元的缺口，全靠在花旗、摩根大通、三菱日联银行（MUFG Bank）三家牵头行的银团贷款来填补。据企业公告，收购完成后，合并实体的净债务与息税折旧摊销前利润（EBITDA）比率预计约为2.3倍。这意味着，合并后公司喘息的时间极短。 太阳制药为何敢这样去赌？欧加隆自身的EBITDA足以覆盖债务利息，整合后的协同效应才是真正的价值增长点。据印度媒体报道，双方管理层预计，合并后实体年营收将达约124亿美元，运营利润约37亿美元，几乎翻番。然而，利润的翻番是以债务的翻番为代价的：太阳制药是否能赢，取决于它能否在债务压顶之前，把欧加隆三大板块中最脆弱的品牌药负增长翻过来。 这里需要解释，欧加隆何以走到被收购这一步。 首当其冲的是核心产品的节节败退。避孕阴道环NuvaRing受仿制药冲击，2025年前三季销量下滑17%；降脂药Atozet因法国等市场丧失独占权，三季度销量跌35%；呼吸科品牌药Singulair因国际市场降价及需求疲软，三季度销量下滑37%。即便是其引以为傲的核心管线皮下避孕植入剂Nexplanon，也因美国医保政策调整，直接导致2025年第四季度销售额骤降20%。唯一保持增长的，只剩下以Renflexis®、Brenzys®、Ontruzant®为代表的生物类似药板块。 紧随其后的是合规风暴。2025年10月，欧加隆内部审计委员会调查发现，公司在2022年至2025年间存在不当销售行为，涉及避孕药产品的批发商销售环节。首任CEO Kevin Ali因此辞职并退出董事会，无遣散费或股权相关退休福利，公司美国商业及政府事务负责人随后也被解雇。消息公布当周，欧加隆股价暴跌逾26%。对于一个以“女性健康”为品牌基石的企业，销售合规丑闻对信任的侵蚀是致命的。 更长期的压力则潜伏在债务端。欧加隆将于2028年面临约36亿美元的大额债务到期。在市值持续缩水、融资能力大幅削弱的格局下，独自扛过这道关口几乎不可能。 正因为如此，当《经济时报》于2026年1月首次披露太阳制药与欧加隆接触的消息时，市场上弥漫的并非惊讶，而是一种“终于来了”的释然。当时传闻的出价区间为100亿至140亿美元，面对市场的躁动，太阳制药一直三缄其口，仅对外表示传闻属于“推测性质”。但知情人士透露，欧加隆方面早已聘任财务顾问为其寻找买家：既要整体出售，也在考虑分拆部分业务。其后，太阳制药挤掉了瑞典EQT与德国Grünenthal的联合报价，以高出对方约16%的规模成功拿下。今年4月初，当《经济时报》再次报道太阳制药正在敲定融资方案、准备递交约束性要约时，欧加隆的股价在盘中一度暴涨18%。 如果说欧加隆的困境是“如何活下去”，那么太阳制药的焦虑则是“如何活得更有价值”。 过去十余年间，太阳制药的并购版图泾渭分明地划为两个阶段。2010年代，从控股以色列仿制药企Taro到2014年以40亿美元收购Ranbaxy，目标明确：扩大规模，抢占全球仿制药市场。 但这种打法正在遭遇越来越逼仄的天花板。全球仿制药正面临严冬。美国市场面临潜在的关税威胁，FDA不断加码对境外药厂的质量检查，分销商集中度提升蚕食了制药企业的议价权。2026年4月，美国宣布拟对创新药和专利药征收100%关税，尽管仿制药暂时豁免，但太阳制药约20%收入来自创新药产品，被分析机构列为“印度最受关税风险冲击的药企”。对太阳制药而言，固守仿制药的“成本优势”就是接受利润率不断被压缩的慢性绞杀。 因此，2020年代以来的并购已然改换逻辑：2023年5.76亿美元的Concert收购，是为了拿下斑秃创新药管线；2025年3.55亿美元的Checkpoint买断，瞄准的是肿瘤专科疗法。而这次以超百亿美元吃下欧加隆，则是太阳制药冲向“品牌与创新价值竞争”的最重的一脚油门。通过欧加隆的产品组合与全球渠道，太阳制药的创新药收入占比将从目前约20%提升至27%，并一举跻身全球女性健康领域前三与生物类似药市场前十。 小结： 整个行业都在屏息注视着这场世纪整合的下一幕。太阳制药要做的，不是简单地“买下一个欧加隆”，而是在两条截然不同的基因之间，在仿制药的低毛利工业逻辑与品牌药的创新生态之间，找到第三条路。 过去十年里，仿制药企靠成本优势占领世界的故事已经写到终章，下一章的主题叫“价值整合”。谁能率先完成这一跨越，谁就能在下一轮全球竞争中拿到入场券；反之，无论是印度的仿制药巨头还是美国的百年老店，都可能在新的产业周期中被边缘化。 封面图来源：即梦AI 超10亿元跨界收购！中赋源创闯入CXO赛道 2026-04-27 MNC在左，罗氏在右 2026-04-25 天鹜科技发布MatwingsVenus™，给AI一个共享实验室 2026-04-25 版权声明/免责声明 本文为原创文章。 本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。 文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。 如有任何问题，请与我们联系。 衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！