Biosimilars

The AJMC® Biosimilars compendium is a comprehensive resource for news and expert insights into these biological products, including clinical research, patent and legal news, and regulatory updates.

Latest News

FDA Approved. | Image Credit: wladimir1804 - stock.adobe.com
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt

March 4th 2025

The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for osteoporosis and bone loss in various patient populations.

FDA Approved. | Image Credit: Nirusmee - stock.adobe.com
First Insulin Aspart Biosimilar Receives FDA Approval

February 20th 2025

Osteoporosis. | Image Credit: Nisit - stock.adobe.com
Denosumab Biosimilars Approved With Interchangeability to Address Osteoporosis, Fracture Risk

February 18th 2025

Insulin. | Image Credit: Sherry Young- stock.adobe.com
Biosimilar Insulin Linked to Lower Prices in Europe

February 12th 2025

FDA approved. | Image Credit: Olivier Le Moal - stock.adobe.com
FDA Approves Celltrion’s Tocilizumab-anoh, Biosimilar to Actemra

January 31st 2025

Continuing Medical Education
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April 25th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy
April 25th 2025

Innovations in Medicine: 2024 Lineup of New and Approved Specialty Drugs

2.0 Credits / General Pharmacy

More News

5 Actions Taken Since the Release of Trump's Drug Pricing Blueprint
August 31st 2018

5 Actions Taken Since the Release of Trump's Drug Pricing Blueprint

Samantha DiGrande
It’s been more than 100 days since President Trump and HHS Secretary Alex Azar announced the “American Patients First” drug pricing blueprint. Here are 5 actions the government has taken since its release.
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August 22nd 2018

Clinical Updates, August 2018

Surabhi Dangi-Garimella, PhD Laura Joszt, MA Kelly Davio Samantha DiGrande
5 Things to Know About the FDA's Biosimilar Action Plan
August 10th 2018

5 Things to Know About the FDA's Biosimilar Action Plan

Kelly Davio
Since biosimilars gained a US approval pathway as part of the Affordable Care Act, these follow-on drugs have been widely seen as a key way to address the problem of high-cost biologic drugs. However, cost savings have been disappointing as only 12 biosimilar products have been approved to date, and just 4 have become commercially available. That’s a reality that led FDA Commissioner Scott Gottlieb, MD, to call the US market for biosimilars “anemic.”
What We're Reading: FDA's Biosimilar Plan; Philly Soda Tax Upheld; Health Subsidy Lawsuit Tossed
July 19th 2018

What We're Reading: FDA's Biosimilar Plan; Philly Soda Tax Upheld; Health Subsidy Lawsuit Tossed

AJMC Staff
FDA Commissioner Scott Gottlieb, MD, announced the release of the agency’s Biosimilar Action Plan; Philadelphia’s tax on soda and other sweetened beverages has been upheld by the Pennsylvania Supreme Court; a federal judge dismissed a lawsuit by 19 states against the Trump administration over the decision to end cost-sharing subsidies under the Affordable Care Act.
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July 5th 2018

Improving Provider and Patient Acceptance of Biosimilars in Treating Cancer

https://www.pharmacytimes.org/on-demand/biosimilars-in-treating-cancer
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June 26th 2018

The Complexities of Biosimilars and the Regulatory Approval Process

Steven Lucio, PharmD, BCPS
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June 26th 2018

Opportunities and Challenges in Biosimilar Uptake in Oncology

Carina Dolan, PharmD, BCOP
5 Things to Know About the CREATES Act
June 22nd 2018

5 Things to Know About the CREATES Act

Kelly Davio
On June 14, 2018, the Senate Judiciary Committee voted 16 to 5 to report the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act to the Senate floor. Here are 5 key things to know about the proposed legislation.
AJMC® in the Press, June 1, 2018
June 1st 2018

AJMC® in the Press, June 1, 2018

AJMC Staff
Coverage of our peer-reviewed research and news reporting in the healthcare and mainstream press.
5 Takeaways From the National Comprehensive Cancer Network's 23rd Annual Conference
March 30th 2018

5 Takeaways From the National Comprehensive Cancer Network's 23rd Annual Conference

Kelly Davio
The National Comprehensive Cancer Network (NCCN)’s 23rd Annual Conference, held March 22-24 in Orlando, Florida, brought together stakeholders from across the oncology landscape. Here are 5 key takeaways from the meeting.
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March 23rd 2018

Managed Care Cast and Not So Different, the AJMC® Podcast Series, Give Experts a Forum

Both Managed Care Cast, from The American Journal of Managed Care®, and Not So Different, the podcast series from The Center for Biosimilars®, offer in-depth discussions of current healthcare issues.
Nine Physician Groups Oppose Proposed Drug Pricing Changes
March 14th 2018

Nine Physician Groups Oppose Proposed Drug Pricing Changes

Allison Inserro
Nine physician groups sent a letter to HHS Secretary Alex Azar Wednesday expressing concern about drug pricing proposals related to Medicare Part B and Medicare Part D that they said would hurt patient care.
This Week in Managed Care: March 9, 2018
March 9th 2018

This Week in Managed Care: March 9, 2018

This week, the top managed care stories included Cigna's deal to buy Express Scripts; Seema Verma, Alex Azar, and Scott Gottlieb, MD, made the rounds at health conferences; an analysis finds FDA's accelerated approval pathway has been a success with hematology and oncology drugs.
Drug Pricing Debate: Panel Talks About Transparency, Legislation
March 9th 2018

Drug Pricing Debate: Panel Talks About Transparency, Legislation

Allison Inserro
Does meaningful competition currently exist in the pharmaceutical industry and is there enough transparency on price? This was the crux of the discussion at the 2018 National Health Policy Conference of America’s Health Insurance Plans in Washington, DC.
5 Things to Know About Biosimilars and Inflammatory Bowel Disease
February 23rd 2018

5 Things to Know About Biosimilars and Inflammatory Bowel Disease

Kelly Davio
Last week, the European Crohn's and Colitis Organisation held its 13th annual congress in Vienna, Austria. At the meeting, researchers presented new data on using biosimilar anti–tumor necrosis factor therapies in treating Crohn disease and ulcerative colitis, 2 manifestations of inflammatory bowel disease. Here are 5 things to know about the research presented.
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February 1st 2018

Biosimilars Update

Coverage from the 59th Annual Meeting and Exposition of the American Society of Hematology, December 9-12, 2017.
This Week in Managed Care: January 12, 2018
January 12th 2018

This Week in Managed Care: January 12, 2018

This week, the top managed care stories included CMS unveiling a new voluntary bundled payment model; coverage from the JP Morgan Healthcare Conference, including immunotherapy's impact on HIV treatment and biosimilars; and news that 2 key diabetes devices will be covered by Medicare.
5 Things From the 36th Annual JP Morgan Healthcare Conference
January 12th 2018

5 Things From the 36th Annual JP Morgan Healthcare Conference

Kelly Davio
This week, the investors and analysts turned their attention to presentations by business leaders at the 36th Annual JP Morgan Healthcare Conference, held in San Francisco, California. Executives from the pharmaceutical and healthcare worlds showcased their products, pipelines, and visions for the future.
Express Scripts Is Built for the Future of Healthcare, Says CEO Wentworth
January 10th 2018

Express Scripts Is Built for the Future of Healthcare, Says CEO Wentworth

Laura Joszt, MA
It’s true, pharmacy benefit managers (PBMs) are complicated, admitted Tim Wentworth, president and CEO of Express Scripts, during his presentation at the JP Morgan Healthcare Conference in San Francisco, California. However, the company is built to succeed in the future of healthcare, he said.
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December 20th 2017

AJMC®tv Interviews, December 2017

The Center for Biosimilars&reg Laura Joszt, MA
AJMC®TV interviews let you catch up on what’s new and important about changes in healthcare, with insights from key decision makers—from the clinician, to the health plan leader, to the regulator. When every minute in your day matters, AJMC®TV interviews keep you informed. Access the video clips at ajmc.com/interviews.
The Switch From Filgrastim to a Cheaper Alternative: Tbo-Filgrastim
December 1st 2017

The Switch From Filgrastim to a Cheaper Alternative: Tbo-Filgrastim

Jaime Rosenberg
With the increasing emergence of less expensive biologic alternatives, some health systems are making the switch. For a large healthcare system, the arrival of a cheaper alternative to filgrastim prompted the conversion to using tbo-filgrastim as the preferrred granulocyte-colony stimulating factor. The results were shared in a study published by the Journal of Managed Care & Specialty Pharmacy.
Clay Alspach Explains How Changes in the FDA Will Affect Biosimilars
November 27th 2017

Clay Alspach Explains How Changes in the FDA Will Affect Biosimilars

Clay Alspach, JD, principal, Leavitt Partners, explains how biosimilars will be affected by changes in the FDA under Scott Gottlieb's leadership.
5 Things to Know About the Nocebo Effect and Biosimilars
November 24th 2017

5 Things to Know About the Nocebo Effect and Biosimilars

Kelly Davio
The “nocebo” effect, a phenomenon that occurs when a patient’s negative perception of a therapy causes a treatment to have a worse outcome than would otherwise be expected, has become a topic of increasing interest in the world of biosimilars as some patients begin to transition from familiar, high-cost biologics to new, lower-cost biosimilars.
5 Highlights From the 2017 ACR Meeting
November 11th 2017

5 Highlights From the 2017 ACR Meeting

Surabhi Dangi-Garimella, PhD
A review of some of the presentations at the American College of Rheumatology (ACR) 2017 Annual Meeting, in San Diego, California, where the discussions ranged from clinical progress witnessed in 2017 for the treatment of inflammatory conditions to reimbursement models in the rheumatology space.
Tesh Khullar: Community Oncologists Need to Understand Impact of Biosimilars on Their Business
November 8th 2017

Tesh Khullar: Community Oncologists Need to Understand Impact of Biosimilars on Their Business

Biosimilars for core therapeutics in cancer are starting to come out, and community oncologists need to understand what that means for their business, as well as what proposed policy changes could mean for reimbursement, explained Tesh Khullar,
In Debate Over Biosimilar Switching, Cost Is Key
November 6th 2017

In Debate Over Biosimilar Switching, Cost Is Key

Kelly Davio
Among the most anticipated sessions at the 2017 meeting of the American College of Rheumatology in San Diego, California was “The Great Debate: Biosimilars…to Switch, or Not to Switch? That Is the Question.”
5 Timely Topics Discussed at the 2017 AMCP Nexus Meeting
October 20th 2017

5 Timely Topics Discussed at the 2017 AMCP Nexus Meeting

Christina Mattina
At this year's Academy of Managed Care Pharmacy (AMCP) Nexus conference, a few trending topics resurfaced across the meeting's agenda, with important implications for pharmacists, payers, and beyond.
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September 13th 2017

Use of Biologic DMARDs Has Increased Among RA Patients

Alison Rodriguez
Amanda Forys on How Biosimilars Are Being Approached on the State Level
September 3rd 2017

Amanda Forys on How Biosimilars Are Being Approached on the State Level

States are addressing biosimilars in different ways and putting different regulations in place as biosimilars become more prevalent in the market, explained Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team.
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August 8th 2017

Medical World News®, August 2017

AJMC Staff
An update on the latest developments in the world of oncology care: product approvals, clinical developments, health policy changes, and more.
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