Influenza Vaccine, Adjuvanted(Seqirus GmbH)

最近，面对欧盟委员会的反垄断调查，赛诺菲不得不公开承认竞争对手CSL Seqirus的流感疫苗Fluad与其自家产品Efluelda具有同等效力，并停止一切贬低竞品的行为。 这场风波的起点是6月26日欧盟委员会对赛诺菲正式启动反垄断调查，调查聚焦于赛诺菲自2024年起在德国和法国针对医疗专业人士开展的一系列推广活动。 Efluelda与Fluad的正面交锋 Fluad是一款佐剂流感疫苗，采用MF59佐剂技术来增强老年人的免疫应答。它的历史可以追溯到1997年在意大利首次获得批准。到2015年11月获得美国FDA批准时，Fluad已在全球38个国家获得许可，包括加拿大和15个欧洲国家。截至获批时，这款疫苗已在全球分发超过1亿剂。 2020年，Fluad从三价升级为四价版本（Fluad Quadrivalent），2月21日获得美国FDA批准，5月20日获得欧盟委员会批准。Fluad Quadrivalent在美国和欧盟均为第一个获批的佐剂四价流感疫苗。 Efluelda实际上更年轻的，是一款高剂量流感疫苗，抗原含量为标准疫苗的4倍。Efluelda于2020年4月1日在欧洲获批上市。更关键的是，Fluad是除了Efluelda本身之外，唯一被推荐用于有风险因素的脆弱患者的竞品流感疫苗。 不过现在看来情况可能要相反，虽说没披露具体销售数据，2025年，赛诺菲疫苗部门总收入约为79亿欧元，Efluelda此前被多家行业媒体描述为该部门的 “关键增长动力”，而 相比之下，Fluad销售额在2025年出现了下滑态势。 在这种新王崛起，旧王走向落幕的激烈背景下，Fluad的形势是岌岌可危。 欧盟的指控 欧盟委员会在初步评估中发现，赛诺菲在德国和法国的增强型流感疫苗市场中可能占据支配地位。正是凭借这一市场地位，赛诺菲被指控实施了可能滥用市场支配地位的行为。 根据欧盟委员会的初步调查，赛诺菲的营销活动涉嫌存在三类违规行为： 其一，贬低竞品的科学证据。 赛诺菲在面向医疗专业人士的沟通中暗示，Fluad的证据基础弱于Efluelda。然而，这一说法与欧洲疾病预防控制中心（ECDC）以及德国和法国国家免疫技术咨询小组（NITAG）的科学评估结论相矛盾。两国NITAG均认为两种疫苗都具有坚实的证据基础，并同等推荐老年人使用。 其二，曲解国家疫苗接种建议。 赛诺菲被指对德国和法国的官方疫苗接种建议进行了误导性和/或不准确的表述。 其三，质疑竞品的官方推荐。 在德国市场，赛诺菲暗示针对Fluad的国家疫苗接种建议仍面临来自医学专业学会的未解决的科学质疑。 欧盟委员会认为，上述行为可能限制了德法两国增强型流感疫苗市场的竞争，涉嫌违反《欧盟运行条约》第102条关于禁止滥用市场支配地位的规定。 在制药行业，贬低竞争对手的行为正日益成为欧盟反垄断执法的重点。2024年10月，欧盟委员会曾对以色列制药公司Teva处以4.626亿欧元的罚款，原因之一便是其针对仿制药竞争对手的系统性贬低宣传。此类制裁可能高达一家公司全球年营业额的10%。 赛诺菲的承诺 当然想规避罚款也是可以的，为化解调查、避免罚款，赛诺菲向欧盟委员会提出了一套涵盖三个层面的承诺方案： 其一是公开承认竞品同等有效。 赛诺菲承诺在其德国和法国官方网站上，连续两年发布声明。德国网站声明将承认德国NITAG已评估Efluelda和Fluad均具有坚实的证据基础，并同等推荐老年人使用；法国网站声明将说明法国NITAG将两种疫苗视为同等效力。赛诺菲还将向德国医疗专业人士直接分发这一声明 其二是纠正营销宣传材料。 赛诺菲承诺在未来四年内，在其德国的增强型流感疫苗营销和推广材料中显著引用德国NITAG的当前推荐。 其三是约束未来言行。 在德国和法国与医疗专业人士的沟通中，赛诺菲承诺不再批评、质疑或反驳适用的国家疫苗接种建议；不再负面描绘Fluad，或暗示Efluelda更安全、更有效——除非此类表述基于欧盟或国家卫生主管部门批准的产品特性摘要（SmPC），或符合特定标准的头对头对比研究；不再使用暗示Fluad证据基础弱于Efluelda的表述，包括通过对涉及Fluad的科学研究进行曲解或有选择性呈现的方式。赛诺菲做出的承诺将持续到2030年3月。他们的执行情况将由一名监督受托人监督，该受托人将定期向委员会报告。 如果该公司不遵守这些承诺，欧盟委员会可能会对其处以高达其全球年营业额10%的罚款，而无需认定其违反了欧盟反垄断法，或者对不遵守规定的每一天处以其每日营业额5%的定期罚款。 不过，赛诺菲的态度就比较有趣了，尽管提交了承诺方案，赛诺菲方面强调，提交承诺不代表承认存在违规行为。公司发言人表示：“赛诺菲仍然相信，公司过去和现在的行为均完全遵守所有适用法律法规，包括竞争法。”公司表示将继续与欧盟委员会合作，以推动程序尽快了结。 参考来源： https://live.euronext.com/en/financial-news/sanofi-stop-disparaging-rival-flu-vaccine-stave-eu-antitrust-fine https://ieu-monitoring.com/editorial/eu-commission-tests-sanofi-commitments-in-flu-vaccine-competition-case/1245250?utm_source=ieu-portal

On the heels of a European Commission probe into whether Sanofi “disparaged” one of its flu vaccine rivals in the marketing of its own shot, the EC is lining up a “market test” to solicit feedback on new promotional commitments offered up by the French pharma. The comment-seeking period and probe tie back to Sanofi’s marketing for its flu shot for adults ages 60 and over, which is marketed as Elfuelda in the European Union, where its only competition is the rival enhanced influenza vaccine Fluad from CSL Seqirus. In announcing the formal investigation in late June, the EC noted that it was concerned Sanofi may have engaged in a “misleading communication campaign” that portrayed Fluad as inferior to its respective vaccine, running afoul of national vaccine recommendations in several EU member states. The campaign mainly targeted healthcare professionals in Germany and France, according to the EC, which also noted that Sanofi’s Elfuelda appeared to hold a dominant position in those markets. Now, after Sanofi put forward proposed pledges about what it will and won’t say regarding its rival’s vaccine, the EC is inviting the public to weigh in on those commitments by Aug. 21. The EC has the power to make the commitments binding on Sanofi until March 2030, which would put the probe to bed without concluding infringement of antitrust rules by the company, following a mandatory comment period for “interested third parties,” according to a July 7 release. In the full text submitted (PDF) by Sanofi to the EC, the French drugmaker stressed that its commitments “do not constitute an acknowledgement that Sanofi agrees with the concerns expressed by the Commission nor an acknowledgement that Sanofi or any of its affiliates have infringed EU competition law.” Digging into Sanofi’s proposed pledges, the company has said that it will publish a statement on its German website for two years that Europe’s National Immunisation Technical Advisory Group (NITAG) in Germany recommends both Efluelda and Fluad “equally for elderly people,” plus a similar statement on its French website, according to the EC. Sanofi has also promised to send its German statement to local healthcare professionals and to include, for four years, a “prominent citation” of the current German NITAG vaccine recommendation in all German marketing and promotional materials for enhanced flu shots. The company has also pledged to avoid “criticizing, casting doubt on or contradicting the applicable national vaccine recommendations issued by the relevant NITAG” and to refrain from “portraying Fluad negatively,” in addition to suggesting that its shot Efluelda is safer or more effective. That could change in the future based on evolving health authority guidance or the results of a head-to-head trial, the EC clarified. Crucially, Sanofi has also committed to refrain from such comments when providing input to key opinion leaders ahead of interactions with healthcare professionals in Germany and France. Should the commitments pass the public comment period and become legally binding, the EC noted that it could impose a fine of up to 10% of its worldwide annual turnover on Sanofi if the company doesn’t honor its pledge. Alternately, the company could face a period penalty payment of 5% per day of its daily turnover for every day in which it’s in noncompliance, the EC added. At the time the EC unveiled its probe last month, Sanofi told Fierce in a statement that it was “confident that it has acted, and continues to act, in full compliance with all applicable laws and regulations, including competition law.”