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
View All
May 14th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy
May 14th 2025

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

2.0 Credits / General Pharmacy

More News

Improving Patient Access to Biosimilars
October 7th 2022

Improving Patient Access to Biosimilars

In her final thoughts, Dr Oskouei discusses how patient care may be improved by increased access to biosimilars.
Image of Medicare report
October 3rd 2022

Medicare Part B Pricing Changes Aimed at Encouraging Biosimilar Use Begin

Allison Inserro
One of the first parts of the landmark Inflation Reduction Act took effect Monday; it boosts the add-on payment for qualifying biosimilars whose average sales price is not more than the price of its reference product from 6% of the reference product’s ASP to 8% for 5 years.
Patient Engagement Strategies to Increase Biosimilar Uptake
September 30th 2022

Patient Engagement Strategies to Increase Biosimilar Uptake

Sonia Oskouei explores the managed care landscape and opportunities for increasing biosimilar uptake to improve patient care.
Paul Forsberg, PharmD, Minnesota Oncology
September 25th 2022

Dr Paul Forsberg: Ensuring Consistent, Clear Messaging Critical During Biosimilar Conversion

Laura Joszt, MA
When converting a patient to a biosimilar, having clear and consistent messaging will reduce confusion and prevent patients from having a lack of trust in the process, said Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.
Gaining Confidence With a Switching Study
September 23rd 2022

Gaining Confidence With a Switching Study

Sonia T. Oskouei, PharmD, BCMAS, DPLA, navigates the impact of the VOLTAIRE-X study, the only published switching study for adalimumab, on biosimilar uptake.
hospital visit
September 20th 2022

Multiple Pegfilgrastim Administration Options Allow for Patient-Centric Model of Care

Laura Joszt, MA
With 6 pegfilgrastim biosimilars approved, and multiple administration options, a patient-centric model of pegfilgrastim administration should be possible for patients with cancer who require prophylaxis of febrile neutropenia.
Site Logo
September 14th 2022

Evaluation of Biosimilar Trastuzumab MYL-1401O in HER2-Positive Breast Cancer

Kadir Eser, MD Emel Sezer, MD Vehbi Erçolak, MD Ali İnal, MD
The authors evaluate the effect and safety of biosimilar trastuzumab MYL-1401O in human epidermal growth factor receptor 2 (HER2)–positive early-stage (neoadjuvant and adjuvant therapy) and metastatic (palliative therapy) breast cancer using real-world data.
Lalan Wilfong, MD, The US Oncology Network
September 11th 2022

Practices Have to Grapple With the Logistics of Insurers’ Preferred Biosimilars: Dr Lalan Wilfong

Laura Joszt, MA Hayden E. Klein
While commercial payers have been engaged with the shift to biosimilars, they all have their own preferred biosimilar, which makes it challenging for practices, explained Lalan Wilfong, MD, vice president of payer relations & practice transformation at The US Oncology Network.
money close up
September 8th 2022

Specialty Drug Trend Is Strong but May Shift With Biosimilars

Laura Joszt, MA
In 2021, the specialty drug trend rebounded from the pandemic, and it is expected to stay strong with more specialty drugs coming. Increased availability of biosimilars could shift this trend.
Paul Forsberg, PharmD, Minnesota Oncology
September 4th 2022

The Biosimilar Conversion Journey Went Through 2 Phases at Minnesota Oncology

Laura Joszt, MA
While initially there was a need for education around biosimilars, now there is a need to keep an eye on the evolving biosimilar marketplace and update the formulary of biosimilar medicines, said Paul Forsberg, PharmD, director of pharmacy, Minnesota Oncology.
Lalan Wilfong, MD, The US Oncology Network
September 1st 2022

Gap After OCM May Cause Some Practices to Switch From Biosimilars to Brand Drugs

Laura Joszt, MA Hayden E. Klein
The 1-year gap after the end of the Oncology Care Model (OCM) means some practices have to make hard decisions regarding cost of care or the financial health of the practice, explained Lalan Wilfong, MD, vice president of Payer Relations & Practice Transformation at The US Oncology Network.
Provider and Payer Demand Largely Drives Biosimilar Adoption to Institution Formularies
August 29th 2022

Provider and Payer Demand Largely Drives Biosimilar Adoption to Institution Formularies

Laura Joszt, MA
Having a biosimilar on formulary makes it more likely the biosimilar will be adopted. Length of time a biosimilar is on market can impact how likely it is to be added to formulary.
rows of identical vials
August 23rd 2022

High-Concentration Version of Adalimumab Biosimilar Will Be Available in 2023

Laura Joszt, MA
The FDA approved the first high-concentration adalimumab biosimilar. A low-concentration version of the biosimilar, Hadlima, was already approved. Both versions will launch in July 2023.
Patients in a waiting room
August 13th 2022

Can Reassurance Techniques Improve Patient Confidence in Biosimilars for Psoriasis?

Laura Joszt, MA
A number of psychologic interventions were assessed to see if they could have an effect on patient confidence in biosimilars to treat psoriasis.
2023 Biosimilars Landscape
August 12th 2022

2023 Biosimilars Landscape

Drs Oskouei and Alboustani discuss implications of multiple biosimilars for adalimumab and how indications are extrapolated for a biosimilar.
Biosimilar and Interchangeable Biosimilar Conversion Programs
August 12th 2022

Biosimilar and Interchangeable Biosimilar Conversion Programs

Drs Atheer Kaddis and Mariam Alboustani delve into biosimilar conversion programs, including switching policies for interchangeability.
molecule
August 10th 2022

Bevacizumab Biosimilar Comparable to Reference Across Disease States

Laura Joszt, MA
The single-center study evaluated patients across multiple cancers to understand the utilization, safety, and financial outcomes of bevacizumab-awwb vs reference bevavizumab.
Automatic Substitution With Interchangeable Biosimilars
August 5th 2022

Automatic Substitution With Interchangeable Biosimilars

Dr Sonia T. Oskouei focuses on automatic substitution in both the pharmacy setting and in patients’ health plans.
Looking at Published Data and Implications of Interchangeability
August 5th 2022

Looking at Published Data and Implications of Interchangeability

Mariam Alboustani, PharmD, discusses the one published example of a switching study and the implications of interchangeability for pharmacists, as well as payers.
identical vials in a row
August 3rd 2022

Data Support Safety, Effectiveness of Biosimilar-to-Biosimilar Switching

Laura Joszt, MA
Although there is a paucity of data of switching among biosimilars of the same reference product, the few studies published support the safety and effectiveness of transitioning patients from one biosimilar to another.
Defining Interchangeable Biosimilars
July 29th 2022

Defining Interchangeable Biosimilars

Drs Kaddis and Oskouei define interchangeable biosimilars, their FDA requirements, and switching studies.
An Overview of Biosimilars and Future Agents
July 29th 2022

An Overview of Biosimilars and Future Agents

Atheer Kaddis, PharmD, and Sonia T. Oskouei, PharmD, BCMAS, DPLA, provide an overview of biosimilars and the preparation for future launches on the horizon.
insulin
July 21st 2022

California Initiative Provides $100 Million to Produce Its Own Insulin Biosimilars

Laura Joszt, MA
The budget allocates half of the money for the development of low-cost interchangeable insulin biosimilars and the other half for building an insulin manufacturing facility in the state.
map of europe
July 21st 2022

Medicines for Europe: Off-Patent Medicines Could Strengthen Europe’s Health Systems

Skylar Jeremias
During its annual conference in Spain, Medicines for Europe shared recommendations for greater use of off-patent medications, such as biosimilars and generics, as a way ensure medicines remain available to patients in light of global events and supply chain issues.
closed eye
July 19th 2022

Ophthalmologists See Promise and Peril, but Lack Familiarity, With Biosimilars

Laura Joszt, MA
Until recently, ophthalmologists in the United States have had no experience with biosimilars, despite the availability of biosimilars for bevacizumab, which is commonly used off label for ophthalmic conditions.
bone image
July 15th 2022

Denosumab Biosimilar Noninferior to Reference Product in Postmenopausal Women

Laura Joszt, MA
The study of postmenopausal women in Iran found the efficacy of the biosimilar was noninferior to the reference product and the safety was comparable after 18 months.
doctor giving a vaccine to an older woman
July 12th 2022

Most Patients Received Inadequate Information on Switching to Biosimilars, Survey Finds

Skylar Jeremias
A survey of patients with breast cancer and oncologists found that when switching to a trastuzumab biosimilar from the reference product (Herceptin), many patients were not given adequate information on what biosimilars are and their benefits.
rows of identical vials
July 7th 2022

Institutions Report Shift to Oncology Biosimilars in Pair of ASCO Abstracts

Laura Joszt, MA
The oncology space has seen successful adoption of biosimilars thanks to processes and formulary decisions driving conversion rates.
Colon
July 2nd 2022

Real-World Outcomes Explored in Studies of Bevacizumab Biosimilar for Metastatic Colorectal Cancer

Lindsey Mulrooney
Abstracts presented at the 2022 American Society of Clinical Oncology Annual Meeting show bevacizumab-awwb to be safe and effective for patients with metastatic colorectal cancer (mCRC) with high overall survival rates.
team of providers
July 1st 2022

The Role of APs in Integrating Biosimilars in Oncology Practice

AJMC Staff
Advanced practitioners (APs) have a role to play in strategies for integrating biosimilars into clinical practice.
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