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Amgen Inc

Amgen is a leading global biotechnology company that develops treatments for serious illnesses.

Lobbying Activity

Meeting with Hildegard Bentele (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · Biotech

Amgen Urges Faster Approvals for Drug-Device Combination Products

3 Oct 2025
Topic — EU initiative to simplify medical device and in vitro diagnostic rules.
Message — Amgen proposes aligning regulations for different types of combination products under a single lead authority. They suggest synchronizing device reviews with medicine applications to ensure faster market entry. Finally, they recommend eliminating duplicate inspections through a formal reliance framework.123
Why — This would significantly reduce product launch delays and administrative costs for companies.45
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Meeting with Olivier Chastel (Member of the European Parliament)

23 Sept 2025 · APAs briefing session on Biotech Act

Meeting with Vlad Vasile-Voiculescu (Member of the European Parliament, Shadow rapporteur)

10 Sept 2025 · Meeting CMA

Meeting with Aurelijus Veryga (Member of the European Parliament)

16 Jul 2025 · Innovative Therapies and Public Health Challenges

Amgen urges EU to streamline biotech regulatory approvals

6 Jun 2025
Topic — The EU is proposing a Biotech Act to accelerate biotechnology market transitions.
Message — Amgen requests a centralized system under the European medicines regulator to fix uncoordinated rules. They propose a faster 120-day approval process for new biotech drugs. They also want to end repetitive safety testing for imports from trusted countries.123
Why — Streamlining approvals would reduce Amgen's administrative expenses and accelerate their product launches.4
Impact — European laboratories would lose business if mandatory local testing for imported drugs is removed.5
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Meeting with Marco La Marca (Cabinet of Commissioner Dubravka Šuica) and Microsoft Corporation and

6 May 2025 · Demographic Policy

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

22 Apr 2025 · Critical medicines act

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

Amgen recommends targeted amendments to the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 to establish a proportionate, risk-based, and EU-coordinated regulatory framework that streamlines drug-IVD clinical trial processes and timelines, reduces administrative burdens, and harmonizes Member State requirements. While the IVDR aims to ensure high-quality diagnostics, its lack of alignment with the Clinical Trials Regulation (CTR) (EU) No 536/2014 creates inefficienciesdelaying access to innovation, increasing costs, and burdening both applicants and regulatory authorities. We fully support EFPIAs position on the need for targeted revisions to address these challenges and restore efficiency and predictability to the regulatory environment. To address these challenges, Amgen recommends the following IVDR revisions: 1. Streamline Performance Study Applications (PSAs) and Clinical Trial Applications (CTAs). - Introduce an integrated EU-wide governance framework to consolidate scientific and regulatory advice across IVDR and medicinal product legislation, ensuring harmonized interpretation among Member States. - Accelerate full EUDAMED deployment to support centralized submissions, improve data-sharing, and enhance coordination for drug-IVD trials. - Harmonize Member State implementation by mandating standardized education, training, and submission practices for PSAs and CTAs, eliminating inefficiencies. 2. Establish a Coordinated EU Assessment Process for Drug-IVD Trials. - Implement an All-in-One coordination process, leveraging the COMBINE project pilot, to integrate submission and assessment for drug-IVD combination trials, reducing regulatory fragmentation. - Introduce a Coordinated EU Assessment Framework, establishing an EU-level body to manage PSA and CTA assessments, ensuring consistency and reducing duplication across Member States. 3. Implement a Risk-Based Approach for Low-Risk IVDs in Medicinal Product Trials. - Exempt low-risk IVDs from unnecessary PSA requirements in medicinal product trials where: the device poses minimal risk to patient safety; and the IVD is not intended for CE marking. - Remove the need for PSAs for CE-marked IVDs when used according to their intended purpose, deferring oversight to Ethics Committees rather than requiring duplicative regulatory submissions. - Allow the use of IVDs approved in other jurisdictions in medicinal product clinical trials to improve trial efficiency. 4. Expand Exemptions for In-House Testing (Article 5.5). - Clarify and expand the in-house exemption to include: devices manufactured and used within EU health institutions; and devices used within central laboratories or clinical research organizations in investigational medicinal product trials. 5. Reduce Regulatory Redundancy and Administrative Burden. - Delete Article 58.2, as Ethics Committees already review retrospective use of left-over samples, making additional notifications redundant. - Delete Article 70.1 and revise Article 70.2, removing the PSA requirement for CE-marked devices used in medicinal clinical trials when not under evaluation, as they are already subject to Ethics Committee review. - Adopt a risk-based approach for legacy IVDs, avoiding unnecessary evidence requirements for long-standing market-approved devices. These targeted amendments will significantly reduce regulatory complexity, streamline approval timelines, enhance Europe's competitiveness in clinical research, and ensure timely patient access to innovative diagnostics. Amgen stands behind EFPIAs broader advocacy to deliver a more efficient and innovation-friendly regulatory environment in the EU.
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Meeting with Angelika Niebler (Member of the European Parliament)

19 Feb 2025 · EU Pharma Policy

Meeting with Pierre Jouvet (Member of the European Parliament)

4 Nov 2024 · Présentation des activités de l'AMGEN en France

Meeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)

10 Oct 2024 · EB Summit

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and American Chamber of Commerce to the European Union and

23 Jan 2024 · Pharmaceutical Package (Regulation)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and

12 Dec 2023 · Directive on Medicinal products for human use

Amgen warns EU pharma rules could stifle orphan drug research

29 Aug 2023
Topic — This consultation evaluates the revision of the EU general pharmaceutical legal framework.
Message — Amgen calls for predictable criteria for unmet medical needs and stronger market exclusivity for orphan drugs. They propose limiting pediatric trial requirements to avoid placing a disproportionate burden on developers.123
Why — Higher incentives and fewer mandatory studies would protect Amgen’s revenue and reduce research costs.45
Impact — Patients with rare conditions may face fewer treatment options if companies prioritize single-use drugs.6
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Amgen warns pharmaceutical reforms will undermine European research investment

29 Aug 2023
Topic — This consultation concerns the revision of the European Union's general pharmaceutical legal framework.
Message — Amgen opposes reporting public research funding and wants the term 'bio-hybrid' removed. They reject tying data protections to launching products in every Member State.123
Why — These changes would reduce administrative overhead and preserve existing market exclusivity periods.4
Impact — Regulators and taxpayers lose transparency regarding public funds used for medical research.5
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Meeting with Deirdre Clune (Member of the European Parliament)

19 Jul 2023 · Pharmaceutical Package

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novartis International AG and

18 Jul 2023 · Directive on Medicinal products for human use

Meeting with Susana Solís Pérez (Member of the European Parliament, Shadow rapporteur)

10 Nov 2022 · EHDS

Response to Cancer Screening Recommendation

14 Feb 2022

Amgen welcomes the opportunity to answer the consultation of the Cancer Screening Recommendation. The implementation of Europe’s Beating Cancer Plan is aligned with our mission to serve patients suffering from cancer. Consolidated, harmonised and strong EU actions engaging multiple stakeholders are necessary to drive a positive change in broad and timely access to cancer care across Europe. We are encouraged by the plan’s emphasis on efforts to diagnose cancer early, a critical step in cancer care to improve outcomes by providing treatment at the earliest possible stage of disease. During the pandemic, cancer screenings significantly decreased, which could seriously impact outcomes. The “Lung Cancer Won’t Wait Report” found that cancer caseloads are still 26-51% below pre-COVID levels.1 The EU backload of screening tests means that 1 million cancer patients could be undiagnosed.2 There is an opportunity to increase screening for all individuals, but it will take partnership and innovation to get there. Lung, prostate and gastric cancer are among the deadliest cancers with respectively 1053, 296 and 266 deaths per day in Europe.3 Including these cancers in screening recommendations may increase the number of people diagnosed early and in turn improve outcomes. A recent meta-analysis demonstrated that screening efforts resulted in a 31% reduction in lung-cancer-related mortality beyond 5 years of follow-up.4 But there is more that can be done. We believe in a proactive approach aiming to predict, and help prevent, cancer progression. A predict and prevent approach can help to improve outcomes, reduce cost, improve population health and deliver sustainable long-term value to the healthcare ecosystem. We are committed to ensuring the latest innovation in cancer precision medicine reaches the right patient at the right time. In addition to screening, expanding access to biomarker testing is needed to help personalise treatment for patients. Targeted therapy, enabled by biomarker testing, is associated with improved outcomes. For example, people living with non-small cell lung cancer (NSCLC) had a 31% reduction in risk of death and a 1.5-fold improved median survival compared to patients with a mutational driver who did not receive targeted therapy.5 Despite clinical guideline recommendations, biomarker testing rates are suboptimal across Europe, with nearly 40,000 NSCLC patients not having the chance to benefit from precision medicine annually.6 Thus, we recommend the Commission consider and address the possible need for increased access not just to screening, but also to biomarker testing at cancer diagnosis. Consideration must also be given to how regulations like the In Vitro Diagnostics Regulation, even with phased implementation, could impact availability of cancer screening tests and biomarker testing for cancer patients in the future.7 In sum, we support efforts to evaluate the scientific evidence to include lung, prostate and gastric cancer in the revised European Screening Recommendations as it could lead to making a meaningful difference in the lives of patients, caregivers and their families, thus having a positive impact on society. References 1) Iqvia. Lung Cancer Won’t Wait 2021: https://www.iqvia.com/insights/the-iqvia-institute/reports/lung-cancer-wont-wait. 2) https://www.europeancancer.org/timetoact/impact/data-intelligence. 3) WHO World Cancer Report, 2020. 4) Rota M, et al. Ann Oncol 2019;30:1040-3. 5) Kris MG, et al. JAMA 2014;311:1998-2006. 6) Malapelle U, et al. J Mol Pathol 2021;2:255-73. 7) https://www.efpia.eu/media/602667/call-to-action-to-the-european-commission-to-postpone-and-facilitate-a-phased-implementation-of-the-in-vitro-diagnostic-regulation.pdf, May 26, 2021.
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Amgen urges EU to shorten drug approvals and digitize leaflets

27 Apr 2021
Topic — The Commission is evaluating the EU's pharmaceutical legal framework to ensure medicine affordability.
Message — Amgen proposes to shorten assessment processes and include rolling review features. They recommend replacing paper patient information leaflets with electronic versions. They also oppose linking incentives to the transparency of R&D costs.123
Why — This would lower administrative burdens and protect the company's financial returns.45
Impact — Smaller countries may face delays if incentives aren't tied to market launches.6
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Amgen warns that reducing incentives stifles rare disease innovation

6 Jan 2021
Topic — The EU is reviewing rules to improve medicine availability for children and rare diseases.
Message — Amgen urges the EU to maintain current market exclusivity rewards and avoid narrowing the definition of unmet medical needs. They oppose tying incentives to mandatory market placement across all member states.123
Why — This would protect the company's financial returns and secure its future investments in high-risk research.4
Impact — Patients with conditions falling outside stricter criteria could lose access to new research.5
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Amgen Urges EU to Protect Pharmaceutical Innovation Incentives

7 Jul 2020
Topic — European Commission consultation on the EU's pharmaceutical strategy and medicine supply chains.
Message — Amgen calls for maintaining strong intellectual property and regulatory incentives to sustain research. They recommend viewing healthcare as an investment and treating the industry as a partner. The company argues price should be recognized as a vital signal to drive innovation.123
Why — Maintaining robust incentives and high prices protects the company's profit margins and competitiveness.45
Impact — Public health systems may face higher costs if drug pricing is not restricted.6
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Meeting with Ursula von der Leyen (President) and Teneo Brussels and Global Citizen

12 Jun 2020 · Videoconference CEO of Amgen and CEO of Teneo (Topic: Preparation of Global Pledging Summit on 27 June)

Meeting with Manuel Mateo Goyet (Cabinet of Commissioner Mariya Gabriel)

17 May 2018 · Digital Health