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 approval with stamp. | Image Credit: Surendra - stock.adobe.com
FDA Approves Seventh Ustekinumab Biosimilar to Reference Stelara

December 20th 2024

The FDA granted approval to Steqeyma (ustekinumab-stba) for inflammatory conditions, making it the seventh biosimilar to reference Stelara after a year of multiple ustekinumab biosimilar approvals.

AJMC
Uptake of Rituximab Biosimilars in Medicare and Medicaid in 2019-2022

December 16th 2024

Seattle Washington skyline | Image Credit: © espiegle - stock.adobe.com
From Approval to Practice: Addressing the Hurdles in Biosimilar Integration

December 12th 2024

Health Policy. | Image Credit: Mohamad Zaki - stock.adobe.com
Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

December 4th 2024

FDA approval. | Image Credit: syahrir - stock.adobe.com
FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

December 2nd 2024

More News

Black patient speaking with doctor | Image credit: Dragana Gordic - stock.adobe.com
December 1st 2023

Patients With Rheumatic Diseases Report Low Satisfaction After Mandatory Biosimilar Switch

Laura Joszt, MA
A mandatory nationwide transition from reference adalimumab to a biosimilar was implemented in New Zealand.
Drug coverage represented by pills, health icons, and a stethoscope | Image credit: janews094 - stock.adobe.com
November 27th 2023

CVS Caremark Switches Up Biosimilar Coverage in 2024

Denise Myshko
As part of updates to its standard formulary, CVS Caremark has removed Amjevita and now prefers Hyrimoz and an unbranded biosimilar.
Person filling out insurance paperwork | Image credit: sodawhiskey - stock.adobe.com
November 21st 2023

HMO and EPO Insurance Plans More Likely to Promote Use of Biosimilars

Lana Pine
Health plan type highly influences the likelihood of biosimilar uptake, with low-flexibility insurance plans more likely to have patients who either switched to a biosimilar or were initiated on a biosimilar.
Stethoscope with health icons next to a piggy bank | Image credit: Kiattisak - stock.adobe.com
November 20th 2023

Biosimilar Substitution Can Reduce TCOC, Improve Provider Performance in Value-Based Payment Models

Laura Joszt, MA
A simulation study estimated the impact of biosimilar substitution on total cost of care (TCOC) and provider financial performance in the final performance period of the Oncology Care Model.
graphic design of a molecule
November 9th 2023

FDA Accepts sBLA for Interchangeability Designation for Adalimumab-bwwd

Emma Andrus
HADLIMA is currently indicated for psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa, among others.
AJMC
November 9th 2023

Rituximab Reference vs Biosimilar Utilization for Oncology vs Nononcology Indications

Bonnie A. Labdi, PharmD, BCOP Rim A. Elbeshbeshy, PharmD Michelle Winkler, PhD, MPH Samuel G. Johnson, PharmD, BCPS Rebecca L. Attridge, PharmD, MSc, BCPS, BCCCP
Reporting on the real-world utilization of reference rituximab and its biosimilars can help show prescribing habits and reveal cost-saving opportunities.
Blue FDA approved stamp
November 1st 2023

FDA Approves First Ustekinumab Biosimilar With Interchangeability Designation

Laura Joszt, MA
Wezlana is the first biosimilar to reference Stelara approved in the United States. The product will launch in 2025.
Older woman's eyes | Image credit: Syda Productions - stock.adobe.com
October 24th 2023

Byooviz Gains Interchangeability Status

Laura Joszt, MA
The ranibizumab biosimilar was the first in ophthalmology to the US market in 2022, but its competition has already had a year of interchangeability exclusivity.
Close up of an older woman's eye | Image credit: Syda Productions - stock.adobe.com
October 18th 2023

Ophthalmology Biosimilars Show Similar Safety, Efficacy to Reference Eylea and Lucentis

Laura Joszt, MA
The results for a proposed aflibercept (Eylea) biosimilar and an accepted ranibizumab (Lucentis) biosimilar were presented at Euretina Congress 2023.
World map with continents represented by different color dots
October 16th 2023

Varying Biosimilar Policies Create Uneven Market Sustainability Across Nations

Skylar Jeremias
The level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.
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.
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.
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