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 30th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy
April 30th 2025

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

2.0 Credits / General Pharmacy

More News

graphic design of a molecule
October 12th 2023

Patient Satisfaction, Drug Survival of Switches to Adalimumab Biosimilars

Laura Joszt, MA
Posters presented at the EADV Congress highlighted that despite similar efficacy, patient perception can affect satisfaction with the switch from the reference adalimumab to a biosimilar.
Bincy Abraham, MD | Image credit: Houston Methodist
October 6th 2023

Dr Bincy Abraham Discusses Working With Payers and Managing Biosimilar Options

Laura Joszt, MA Pearl Steinzor
Providers have to know how to manage patients who are hesitant to switch to a biosimilar and payers who have specific preferences about which biosimilar to use.
Blue FDA Approved stamp | Image credit: Olivier Le Moal - stock.adobe.com
October 5th 2023

First Tocilizumab Biosimilar Approved in the United States

Skylar Jeremias
The FDA has approved Tofidence, the first tocilizumab biosimilar in the United States, which will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
What We’re Reading: Drug Price Negotiation Participants; Boehringer Debuts Low-Cost Biosimilar for Humira; Schools Stocking Naloxone Controversy
October 3rd 2023

What We’re Reading: Drug Price Negotiation Participants; Low-Cost Biosimilar for Humira; Schools Stocking Naloxone

AJMC Staff
Major companies committed to joining Medicare drug price negotiations; Boehringer Ingelheim introduced a low-cost version of its adalimumab biosimilar; schools begin to stock naloxone amid rising opioid deaths among young people.
Close up of older woman's eye | Image credit: Syda Productions - stock.adobe.com
September 29th 2023

Biosimilars Could Help With Increasing Costs for AMD Therapies in Medicare

Justina Petrullo
Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (AMD) that could increase Medicare costs, but biosimilars could help.
Screenshot of Christine Pfaff, RPh, during a Zoom video interview
September 23rd 2023

Biosimilars Had a Huge Impact on Total Cost of Care, Says AON’s Christine Pfaff

Maggie L. Shaw Laura Joszt, MA
In a few short years, biosimilars have driven down total cost of care in oncology through providing competition for expensive drugs, explained Christine Pfaff, RPh, senior regional director of operations, American Oncology Network (AON).
artwork of a health care price tag being cut | Image credit: retrostar - stock.adobe.com
September 22nd 2023

Biosimilar Competition Erodes Humira’s Market Share; Amjevita Leads the Pack

Laura Joszt, MA
A survey of gastroenterologists, dermatologists, and rheumatologists found Amjevita had the most recognition, followed by Cyltezo, the only interchangeable biosimilar on the US market.
group of people icons with one highlighted red | Image credit: vegefox.com - stock.adobe.com
September 16th 2023

Switching Back to Originator From Biosimilar Infliximab Results in Higher Discontinue Rates

Laura Joszt, MA
One-fourth of patients who switched to an infliximab biosimilar retransitioned back to the originator, but they were more likely to subsequently discontinue treatment due to an unwanted response after switching back.
Medicine on top of 100 dollar bills | image credit: Nikitos77 - stock.adobe.com
September 15th 2023

AAM Report: Generics and Biosimilars Generate $408 Billion in 2022

Skylar Jeremias
A report from the Association for Accessible Medicines (AAM) highlighted the value of biosimilars and generics, revealing that lower-cost versions of originator products accumulated $408 billion for the US health care system in 2022.
CVS Health sign | Image credit: JHVEPhoto - stock.adobe.com
September 9th 2023

CVS Launches New Biosimilars Brand

Skylar Jeremias
Cordavis is a new subsidiary from CVS Health Corporation that will work with manufacturers to commercialize and coproduce biosimilars, beginning with an adalimumab product.
close up of money
September 8th 2023

New Nonbiosimilar Drugs Account for Majority of Part B Drug Spending Increases

Laura Joszt, MA
Drug spending for products facing generic or biosimilar competition decreased during the same time period.
Screenshot of Laura Wingate in a Zoom interview
September 3rd 2023

Laura Wingate: Biosimilars Can Improve Access to Treatment for Patients

Laura Joszt, MA
Biosimilars can improve access to treatment for patients who might not have been able to access biologics previously, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.
illustration of health care price tag being cut in half with scissors
August 31st 2023

Stelara and Enbrel Chosen for IRA Price Negotiation

Skylar Jeremias
The Biden administration has released the first 10 drugs subject to price negotiation with Medicare under the Inflation Reduction Act (IRA), and among those chosen were Stelara (ustekinumab) and Enbrel (etanercept), both of which will face biosimilar competition within the next decade.
FDA in black lettering on gray background
August 25th 2023

FDA Approves Natalizumab Biosimilar, First for Multiple Sclerosis

Laura Joszt, MA
The FDA has approved the first biosimilar to treat multiple sclerosis, Sandoz's injection treatment natalizumab-sztn (Tyruko).
EBO thumb
August 16th 2023

Understanding Interchangeable Biosimilars at the Federal and State Levels

Sophia Humphreys, PharmD, MHA, BCBBS
Screenshot of Laura Wingate in a Zoom interview
August 15th 2023

Laura Wingate Discusses Patient Education for Biosimilar Switches vs New Starts, Interchangeability

Laura Joszt, MA
Greater attention needs to be on educating patients who are switching from a reference product they are successful on to a biosimilar than a patient who is starting a treatment with a biosimilar at the beginning of their disease journey, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.
stethoscope on business papers
August 8th 2023

Amgen Announces $19M in Q2 Revenue From Amjevita; Humira Down 26% in US

Laura Joszt, MA
Amjevita’s revenue was down 63% in the second quarter (Q2) compared with the first quarter of 2023, when the biosimilar launched.
Screenshot of Laura Wingate in a Zoom interview
August 3rd 2023

Laura Wingate: Education Makes Patients More Confident in Biosimilar Switches

Laura Joszt, MA
There is a right way and a wrong way to inform a patient about a switch from the reference product to a biosimilar, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.
Empty pharmacy shelves because of drug shortages | Image credit: OntheRun Photo - stock.adobe.com.
July 30th 2023

AAM White Paper Offers Causes and Solutions to the US Generic Drug Shortage

Skylar Jeremias
A white paper crafted by the Association for Accessible Medicines (AAM) outlined that main causes of generic drug shortages and recommended several actions for stakeholders to remedy current shortages and prevent future ones.
Screenshot of Laura Wingate in a Zoom interview
July 24th 2023

Laura Wingate on the Unique Situation of 7 Adalimumab Biosimilars Coming to Market at Once

Laura Joszt, MA
Despite having 8 adalimumab biosimilars on the market now, patients may only see 1 or 2 available through their insurance, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.
doctor writing a prescription
July 21st 2023

Despite Steep Discounts, Humira Biosimilars Are Priced More Than Original Originator Price

Skylar Jeremias
Even at a steep discount, the list prices of new adalimumab biosimilars are significantly higher than the original price of the originator product (Humira), highlighting how dramatically its list price has risen over the years.
Three insulin needs in a row
July 18th 2023

Payer Controls Limiting Semglee Uptake Despite Patient Demand

Laura Joszt, MA
A new analysis finds branded insulin glargine (Lantus) still has a majority of total market volume and new drug starts despite competition from Semglee, an interchangeable biosimilar.
Screenshot of Laure Wingate, of Crohn's & Colitis Foundation, during a Zoom interview
July 15th 2023

Patient Education Can Prevent Nocebo Effect With Adalimumab Biosimilars, Explains Laura Wingate

Laura Joszt, MA
As Humira biosimilars enter the market, patient education about biosimilars is crucial to prevent the nocebo effect when patients switch from the reference product, explained Laura Wingate, executive vice president, Education, Support, & Advocacy, Crohn's & Colitis Foundation.
stethoscope on money
July 13th 2023

Price Discounts Have Driven Higher Biosimilar Usage, Especially in Oncology

Laura Joszt, MA
A report from Samsung Bioepis highlighted the positive correlation between biosimilar usage and average sales price discounts, with the oncology space being more price sensitive than other areas.
stethoscope laying on top of charts
July 5th 2023

Oncology Practices Made Shifts Toward Biosimilar Use, but Payer Challenges Remain

Laura Joszt, MA
Two abstracts presented at the 2023 American Society of Clinical Oncology annual meeting evaluated biosimilar adoption across oncology practices and highlighted the role payers play in preventing or promoting adoption.
Adam Colborn, JD
July 3rd 2023

AMCP's Adam Colborn Explains Obstacles, Solutions for Interchangeability in the Biosimilars Market

Hayden E. Klein
Adam Colborn, JD, director of government relations at the Academy of Managed Care Pharmacy (AMCP), also explains what health systems can do to improve patient access to biosimilars.
hexagonal shapes on a blue background
June 29th 2023

The Wait Is Over: 8 Adalimumab Biosimilars Launching in the US in July

Laura Joszt, MA
After 7 years, competition for Humira is here. The first adalimumab biosimilar launched in January, but an additional 8, including an interchangeable product, will hit the US market in July.
Scott Soefje, PharmD
June 28th 2023

Dr Scott Soefje Says New Biosimilar Workflow "Completely Simplified the System"

Hayden E. Klein
Scott Soefje, PharmD, director of pharmacy cancer care at Mayo Clinic, explains how education can help with biosimilar adoption and how an updated biosimilar workflow has simplified the prior authorization process.
Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030
June 24th 2023

Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030

Laura Joszt, MA
The Act4Biosimilars Action Plan seeks to increase biosimilar adoption by at least 30 percentage points in 30-plus countries by 2030.
Scott Soefje, PharmD
June 20th 2023

Dr Scott Soefje on the Role of Biosimilars in Global Drug Spending and Why Interchangeability Is Important

Hayden E. Klein
Biosimilars are starting to make a significant impact in overall drug spending, which is what they are designed to do, said Scott Soefje, PharmD, director of pharmacy cancer care at Mayo Clinic.
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