Manufacturer Profile:
Amgen

Amgen is a global biotechnology leader with more than 45 years of experience developing, manufacturing and delivering innovative biologics and biosimilar medicines. The company is led by executives Robert Bradway, Chairman and CEO; Murdo Gordon, Executive Vice President, Amgen Global Markets and Policy; and Paul Burton, Senior Vice President and Chief Medical Officer. The Biosimilars Business Unit is led by Marc Doble, Vice President and General Manager.
Amgen entered the biosimilars arena in 2011 following passage of the Biologics Price Competition and Innovation Act, drawing on decades of biologics innovation and manufacturing expertise. Since then, Amgen has invested more than $2 billion across its portfolio of 11 approved or in-development biosimilar medicines, focusing primarily on oncology, inflammation and rare diseases, while expanding into new therapeutic areas like ophthalmology (see approved product table). Amgen’s biosimilars portfolio continues to deliver results, generating more than $13 billion in sales worldwide as of the first quarter of 2026.
Looking ahead, the company has reiterated its commitment to further invest in biosimilars, aiming to reach more than $4 billion in annual biosimilar sales by 2030.
As a top U.S.-headquartered biosimilar manufacturer, Amgen stands out in the field by fully integrating its innovative biologics and biosimilars teams and facilities, allowing its biosimilars to benefit from the same world-class scientific expertise, rigorous quality systems and reliable supply network that support its innovative medicines. Advances in Amgen’s end-to-end manufacturing have further strengthened the company’s biosimilar capabilities; its technologies are more precise, more quantitative and more advanced than ever before, enhancing Amgen’s ability to deliver high-quality, reliable biosimilars that align with real-world patient needs.
Amgen believes the marketplace with biosimilars is in a critical phase where long-term growth and sustainability rely on policies that: foster a stable, predictable environment for developing and delivering biosimilars; uphold rigorous, science-based regulatory standards; and promote marketplace competition between biosimilars and originator biologics.
Why you may be hearing more about Amgen:
Guided by the needs of patients and informed by the company’s experience in innovative oncology treatments, Amgen is investigating new immuno-oncology biosimilars to OPDIVO® (nivolumab) (ABP 206) and KEYTRUDA® (pembrolizumab) (ABP 234). In addition, Amgen is investigating a biosimilar (ABP 692) to the top-selling CD20 antibody OCREVUS® (ocrelizumab) for multiple sclerosis.
Alongside announcing recent manufacturing expansions across facilities in Ohio and North Carolina, Amgen is investing more than $600 million in a new state-of-the-art Science & Innovation Center at its headquarters in Thousand Oaks, California. The new center will bring researchers, engineers and manufacturing teams together to advance the development and delivery of biological medicines, including biosimilars.
As Amgen advances its biosimilars pipeline, the company sees a clear opportunity to strengthen the marketplace with biosimilars by encouraging reliable choice across therapeutic areas and supporting long-term value for healthcare systems. A robust and competitive marketplace has the potential to ease cost pressures for patients, providers and payers. By investing in high-quality biosimilar development, Amgen is helping to create a more sustainable environment that delivers meaningful savings today while supporting future innovation across the healthcare ecosystem.

Inside Biosimilars: Learn how Amgen manufactures and delivers its medicines
Click here to watch the full Inside Biosimilars series from Amgen
Amgen News & Commentary
Update on Amgen’s PAVBLU® Launch Success
(February 13, 2026) The February 3 earnings report released by Amgen underscores the major success of its PAVBLU® launch, the first biosimilar competitor to EYLEA®. For the full year 2025, US net sales were $691 million, the company’s most successful biosimilar launch to date.
‘That’s Our Secret Sauce’: Amgen’s Doble on Biosimilar Success and the Next Chapter
(September 4, 2025) The same people, processes and infrastructure that develop and manufacture Amgen’s originator biologics also support its biosimilars, the Vice President and General Manager of Amgen’s Biosimilars Business Unit, Marc Doble, explains.
Unlocking the Future of Biosimilars: Why Biosimilars Hold the Key to a More Sustainable Health Care System
(April 28, 2025) Hosted by Amgen and POLITICO, the “From Policy to Patients: Shaping the Next Era of Biosimilars” roundtable included leaders across biopharmaceutical, policy and patient advocacy sectors. Experts explored the pivotal role that biosimilars play in strengthening the health care system and how stakeholders can work together to ensure continued marketplace growth.
Amgen’s PAVBLU® Makes Significant Inroads into the Aflibercept Market
(December 9, 2025) Amgen’s aflibercept biosimilar PAVBLU® has rapidly captured significant revenues, despite Regeneron’s shift to EYLEA HD®, signaling strong payer uptake.
With Recent Launches and More to Come, Amgen's Biosimilar Business is Trending up
(February 5, 2025) During the company’s Q4 2024 earnings call, Amgen reported that its biosimilars portfolio revenues increased by 16 percent to $2.2 billion, with sales expected to reach $4 billion by the end of the decade.
Amgen Scores FDA Approval of First Eculizumab Biosimilar
(May 30, 2024) On May 28, 2024, the FDA approved Amgen’s BKEMV® as the first biosimilar for Alexion’s SOLIRIS®, a complement inhibitor. The biosimilar was approved as interchangeable.
First Biosimilar Interleukin Approved by the FDA: Amgen’s WEZLANA™ is Interchangeable with STELARA®
(November 1, 2023) On October 31, the FDA announced that Amgen’s biosimilar ustekinumab received approval as an interchangeable product, marking the first biosimilar approval in this drug category.
Amgen’s Leah Christl Makes the Case to Keep the Interchangeability Designation for Biosimilars
(September 12, 2023) “We don’t support doing away with the interchangeability standard or making all biosimilars interchangeable by default,” said Leah Christl, Amgen’s Executive Director for Global Biosimilars Regulatory Affairs. She called for the FDA to retain its remit and not diminish confidence in the market by making any major changes early on.
Advancing Global Harmonization of Biosimilar Evaluations
(March 27, 2023) On a panel at the 2023 Festival of Biologics in San Diego, Leah Christl, Executive Director for Global Biosimilars Regulatory Affairs at Amgen discussed how harmonization of global regulatory standards could improve adoption of biosimilars.
Amgen Launches AMJEVITA® With Two WAC-Based Pricing Options
(February 1, 2023) Amgen announced the launch of AMJEVITA®, the first Humira biosimilar, using a dual pricing strategy: a high-WAC option with substantial rebates aimed at pharmacy benefit managers who favor rebate-driven contracting, and a 55% discounted low-WAC option designed for health plans and systems that prefer lower list prices—positioning AMJEVITA® to compete aggressively across both segments of the adalimumab market.
Amgen’s FDA-Approved Biosimilars
| Drug Name | Nonproprietary Name | Drug Class |
AMJEVITA® |
adalimumab-atto |
Anti-TNF-alpha inhibitor |
PAVBLU® |
aflibercept-ayyh |
VEGF inhibitor |
MVASI® |
bevacizumab-awwb |
VEGF inhibitor |
BKEMV® |
eculizumab-aeeb |
Complement inhibitor |
AVSOLA® |
infliximab-axxq |
Anti-TNF-alpha inhibitor |
RIABNI® |
rituximab-arrx |
CD20 inhibitor |
KANJINTI® |
trastuzumab-anns |
HER2/neu-receptor antagonist |
WEZLANA™ |
ustekinumab-auub |
Interleukin 12/23 inhibitor |
Amgen’s Biosimilar Pipeline
| Drug Name | Reference Product | Status |
ABP 206 |
OPDIVO® |
Undergoing comparative clinical efficacy study |
ABP 234 |
KEYTRUDA® |
Undergoing comparative clinical efficacy study |
ABP 692 |
OCREVUS® |
Undergoing comparative clinical efficacy study |
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company; KEYTRUDA® is a registered trademark of Merck Sharpe & Dohme Corp; OCREVUS® is a registered trademark of Genentech, Inc. |
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