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 26th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy
April 26th 2025

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

2.0 Credits / General Pharmacy

More News

cost of health care represented by various icons and a physician
June 14th 2023

SmithRx to Offer Adalimumab Biosimilar Yusimry at 90% Discount to Humira

Laura Joszt, MA
The pharmacy benefit manager SmithRx has announced that through a partnership with the Mark Cuban Cost Plus Drug Company, it will offer Yusimry, an adalimumab biosimilar, for less than 90% of the cost of the reference product, Humira.
toy shopping cart of medications sitting on a laptop | credit: evso - stock.adobe.com
June 8th 2023

Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar

Skylar Jeremias
The Mark Cuban Cost Plus Drug Company, an online pharmacy dedicated to increasing access to lower-cost prescriptions, is partnering with Coherus Biosciences to distribute Yusimry, a biosimilar referencing Humira. It’s the first time the pharmacy has added a biosimilar to its list of drugs.
illustration of cutting health care costs
June 5th 2023

Trastuzumab Biosimilars Successfully Drove Down Prices

Laura Joszt, MA
When multiple trastuzumab biosimilars entered the US market in quick succession, they were able to do something other biosimilars have not in the United States: drive down the cost of the originator biologic.
rows of identical vials
June 2nd 2023

Mandatory Switch Policies Drive Biosimilar Uptake, Reduce Costs

Laura Joszt, MA
Abstracts presented at EULAR 2023 highlighted the impact that a mandatory switching policy had on biosimilar uptake in British Columbia, Canada, and the lack of uptake when no such policy was in place in the United States.
close up of money
June 1st 2023

340B Program May Be Reducing Biosimilar Uptake

Laura Joszt, MA
New research has found the 340B program is slowing uptake of biosimilars by incentivizing use of more expensive biologics.
Asembia 2023
June 1st 2023

What You May Have Missed at Asembia 2023

AJMC Staff
The 2023 Asembia Specialty Pharmacy Summit took place in early May in Las Vegas, Nevada, and The American Journal of Managed Care® was there to cover the meeting—catch up on what you may have missed.
Red FDA Approved stamp on white background
May 25th 2023

Ninth Adalimumab Biosimilar, Yuflyma, Approved in the US

Laura Joszt, MA
The FDA approved Celltrion Healthcare’s Yuflyma (adalimumab-aaty), which is a high-concentration, citrate-free formulation.
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May 22nd 2023

Provider Barriers in Uptake of Biosimilars: Case Study on Filgrastim

Jessica Chang, MA Pinar Karaca-Mandic, PhD Ronald S. Go, MD Stephen Schondelmeyer, PharmD, PhD Daniel Weisdorf, MD Molly Moore Jeffery, PhD, MPP
Previous studies have found modest uptake of biosimilars in both commercial and Medicare populations. This study finds that the uptake varies between the rural and urban provider settings.
biosimilar molecule
May 19th 2023

Pegfilgrastim Biosimilar Fylnetra Launches in the United States

Skylar Jeremias
Amneal Pharmaceuticals this week launched its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.
stack of $100 bills next to stack of pills
May 13th 2023

Patient Joins PQA23 Panel on IRA’s Potential Impact on Medication Access, Affordability

Hayden E. Klein
At the Pharmacy Quality Alliance (PQA) 2023 Annual Meeting, a patient joined a panel to give insight into the challenges of living with a chronic illness and what he sees as the pros and cons of the Inflation Reduction Act (IRA).
image of government health care spending
May 12th 2023

340B Eligibility Translates Into Lower Biosimilar Uptake, Study Says

Allison Inserro
The results indicate that the program could play a role in discouraging use of biosimilars in the United States.
Fran Gregory, PharmD, vice president of emerging therapies, Cardinal Health.
May 8th 2023

Dr Fran Gregory Discusses the Impact of the New Wave of Biosimilars on Rebate Practices

Pearl Steinzor
Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses the role the new wave of biosimilars will have on rebate practices for both pharmacy benefit managers (PBMs) and payers.
image depicting scientific research
May 5th 2023

Despite Concerns Over Extrapolation, Bevacizumab Biosimilars Are Widely Used in mCRC

Deanna Ferreri, PhD
A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.
Screenshot of Margaret Rehayem of National Alliance of Healthcare Purchaser Coalitions
May 3rd 2023

Margaret Rehayem Discusses How Employers Should Look at Their Humira Biosimilar Strategy

Laura Joszt, MA
Oncology has been an easy area for employers to adopt biosimilars because of the rising costs in the space, said Margaret Rehayem, vice president, National Alliance of Healthcare Purchaser Coalitions. Now that multiple adalimumab (Humira) biosimilars are hitting the US market, employers should take a step back to review their current strategy around the drug.
Clinical Research Concept with Medical Icons on Light Bulb: © ArtemisDiana - stock.adobe.com
May 2nd 2023

Study Identifies Factors That Influence Bioequivalence Evaluations of Insulin Biosimilars

Gianna Melillo
These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote.
Screenshot of Margaret Rehayem of National Alliance of Healthcare Purchaser Coalitions
April 28th 2023

Margaret Rehayem: Rebates Remain Influential and a Barrier to Biosimilar Adoption for Employers

Laura Joszt, MA
Rebates remain very attractive for many employers, but they should push back on the reliance on rebates that may be preventing biosimilars from being added to formularies, said Margaret Rehayem, vice president, National Alliance of Healthcare Purchaser Coalitions.
image of a folder marked health insurance
April 22nd 2023

Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars

Skylar Jeremias
A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
Screenshot of Margaret Rehayem of National Alliance of Healthcare Purchaser Coalitions
April 20th 2023

There Remains a Need to Educate Employers, Employees on Biosimilars: Margaret Rehayem

Laura Joszt, MA
While employers fall on a spectrum when it comes to knowledge and understanding of biosimilars, there does remain a need to educate them, as well as for them to educate their employees, said Margaret Rehayem, vice president, National Alliance of Healthcare Purchaser Coalitions.
Screenshot of Margaret Rehayem of National Alliance of Healthcare Purchaser Coalitions
April 13th 2023

Margaret Rehayem Highlights Strategies From the Employer Playbook on Biosimilars

Laura Joszt, MA
The Employer Playbook on Biosimilars highlights strategies employers can use to navigate challenges around ensuring employee access to biosimilars at the pharmacy, as well as how to respond to pharmacy benefit managers who aren’t making biosimilars available on the formulary, said Margaret Rehayem, vice president, National Alliance of Healthcare Purchaser Coalitions.
Kathy Oubre, MS, CEO of Pontchartrain Cancer Center
April 12th 2023

Kathy Oubre Discusses Challenges With PBMs and Payers in the Biosimilar Market

Pearl Steinzor
Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discusses the use of biosimilars and how pharmacy benefit managers (PBMs) as well as payers have challenged the biosimilar market.
cutting costs visualized by someone cutting a price tag in half
April 10th 2023

Biosimilars Can Create Huge Savings, but Interchangeability Needs to Be Reviewed

Laura Joszt, MA
A new report from AHIP indicates that biosimilars have the potential to garner savings of $180 billion over 5 years, but there needs to be a review of the approval process for interchangeability to encourage more approvals.
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April 8th 2023

Biosimilars Are Mighty, Can Help Alleviate Drug Spend Cost Burden

Maggie L. Shaw
With the global market for biologics estimated at $382 billion just last year, and a projected global drug spend of close to $1.5 trillion by 2027, the landscape is ripe for biosimilars to help decrease the health care system’s cost burden.
Canada on a globe with a green pin | Image Credit: © zerophoto - adobe.stock.com
April 1st 2023

More Canadian Jurisdictions Implement Mandatory Biosimilar Switching Policies

Laura Joszt, MA
The province of Newfoundland and Labrador and the territory of Yukon both announced biosimilar switching policies, bringing Canada to a total of 10 out of 13 jurisdictions have a policy in place.
Brown skin | Image credit: © PixieMe - adobe.stock.com
March 29th 2023

AAD Posters Address Misconceptions, Concerns Regarding Biosimilar Use in Dermatology

Laura Joszt, MA
Two posters presented at the American Academy of Dermatology (AAD) annual meeting evaluated misconceptions and addressed concerns around the use of biosimilars in dermatology.
FDA image
March 24th 2023

FDA Approves Sandoz’ High-Concentration Version of Adalimumab Biosimilar, Hyrimoz

Allison Inserro
Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).
rendering of a biosimilar molecule
March 18th 2023

Biosimilars May Not Be Cheap, but Are "Helping to Make Cancer Therapies More Accessible," Expert Says

Alana Hippensteele
Biosimilars may not be perfect, but they are, at the very minimum, helping to make cancer therapies a little bit more accessible, said Andre D. Harvin, PharmD, MS, executive director of pharmacy, oncology, Cone Health.
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March 13th 2023

Neulasta Onpro: A Coup de Grâce?

Chelsee J. Jensen, PharmD, BCPS Caleb J. Scheckel, DO Ronald S. Go, MD Aakash Desai, MBBS, MPH Scott A. Soefje, PharmD
With the rapid decline in average sales price of reference pegfilgrastim products due to biosimilar competition, health care institutions and payers may grapple with coverage of Neulasta Onpro.
Stethoscope on financial papers | photo credit: shahrilkhmd - stock.adobe.com
March 9th 2023

Employer Playbook Suggests Strategies for Biosimilar Adoption, Navigating Adalimumab Launches

Laura Joszt, MA
A new resource from the National Alliance of Healthcare Purchaser Coalitions aims to help plan sponsors adopt biosimilars into their pharmacy benefit plans.
Image representing biosimilars: hafakot - stock.adobe.com
March 8th 2023

New WHO Biosimilar Guidelines Aim to Streamline, Clarify Regulations

Jared Kaltwasser
The new recommendations from the World Health Organization (WHO) urge viewing the totality of evidence when evaluating biosimilar products.
AJMC The Center for Biosimilar logo
March 4th 2023

Biosimilar News Round-up: Insulin Biosimilar Discount, Infliximab Adherence, and More

AJMC Staff
A roundup of the latest biosimilar news from The Center for Biosimilars®.
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