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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May 24th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy
May 24th 2025

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

2.0 Credits / General Pharmacy

More News

people in suits sitting around a table talking
March 22nd 2022

Panel on Prior Authorization Reveals Role PBMs Play in Biosimilar Uptake in Oncology

Skylar Jeremias
During the recent Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the laser focus on rebates by pharmacy benefit managers (PBMs) may be hindering uptake of biosimilars, thereby keeping some off of formulary lists.
Health care cost image
March 17th 2022

Researchers Find Varied Uptake of Biosimilars in Medicare Part D

Laura Joszt, MA
While filgrastim biosimilars had substantial uptake, there was low uptake of infliximab biosimilars. In addition, there was a lack of price competition.
Julie M. Reed
March 14th 2022

Julie Reed Previews 2022: The Year of Expanded Access to Biosimilars

Skylar Jeremias
As the United States awaits market introduction for adalimumab biosimilars in 2023, 2022 is going to be the year of expanding access to biosimilars, according to Julie M. Reed, the new executive director of the Biosimilars Forum.
identical vials of medicine lined up
March 9th 2022

Biosimilars Present an Exciting Opportunity for Cigna’s Evernorth, Says CEO Palmer

Laura Joszt, MA
After years, the biosimilars horizon may be here with valuable opportunities to improve patient outcomes and reduce costs, said Eric Palmer, president and CEO of Evernorth.
health care delivery and cost
March 6th 2022

Employers Highlight Barriers to Biosimilar Adoption

Laura Joszt, MA
A lack of transparency and misaligned incentives had curtailed the adoption of biosimilars in the United States.
FDA logo
March 3rd 2022

FDA Approves Third Filgrastim Biosimilar: Releuko

Skylar Jeremias
Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, becomes the third filgrastim biosimilar to be approved by the FDA.
Biocon Biologics and Viatris logos
March 1st 2022

Viatris Sells Biosimilars Business to Biocon Biologics

Skylar Jeremias
Biocon Biologics announced that it will be acquiring Viatris’ biosimilars portfolio for close to $3 billion.
Julie M. Reed
February 25th 2022

The Biosimilars Forum's Julie Reed Predicts How Interchangeability Will Impact Biosimilar Uptake

Skylar Jeremias
Julie M. Reed, the new executive director of the Biosimilars Forum, offers her opinion on how interchangeability will impact US biosimilar uptake now that the FDA has given the designation to 2 biosimilars.
Purva Rawal, PhD
February 21st 2022

CMS Official Cites OCM as Example of Biosimilar Success

Mary Caffrey
Purva Rawal, PhD, senior advisor and chief strategy officer, Center for Medicare and Medicaid Innovation, addressed attendees at the Association for Accessible Medicines' Access! annual meeting, held in Orlando, Florida, February 15-16.
health care cost
February 16th 2022

Biosimilars Available for 3 Drugs Costing More Through Hospitals, Physicians

Laura Joszt, MA
AHIP released a report looking at the price markups for 10 drugs that can be delivered more affordably through specialty pharmacies, including 3 drugs with multiple biosimilars available.
syringe stuck in a vial
February 14th 2022

A Review of Biosimilars in 2021: Regulatory, Legal Developments, and What’s in Store for the New Year

Skylar Jeremias
Although the COVID-19 pandemic has led to mass slowdowns in drug approvals and biosimilar launches, 2021 signaled a stronger focus on biosimilars going forward, with new regulatory bills and a crackdown on anticompetitive practices.
Remsima
February 11th 2022

VA Study: Patients Switching to Biosimilar Infliximab More Likely to Stop Treatment

Mary Caffrey
Physician and patient resistance to switching from an innovator or reference product to a biosimilar—or from one biosimilar to another—constitutes one of the major barriers to biosimilar adoption, despite the cost savings that can be achieved.
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February 9th 2022

Real-world Usage of Bevacizumab-bvzr Biosimilar in US Oncology Practice

Jingyan Yang, DrPH, MHS John Mark Kelton, PharmD Jeffrey Thompson, PhD Jose Maria Jimenez Alvir, DrPH Martine C. Maculaitis, PhD Ahmed Shelbaya, MD
Real-world adoption of bevacizumab-bvzr biosimilar was retrospectively assessed, revealing switching between biosimilars and the reference product and utilization in extrapolated indications and combination regimens.
Bruce Feinberg, DO
February 8th 2022

Payers, Value-based Care Policies Impact Biosimilar Adoption, Cardinal Health Report Finds

Mary Caffrey
Cardinal Health's report, “2022 Biosimilars Report: The U.S. Journey and Path Ahead,” outlines how biosimilars will move beyond their comfort zones in oncology and rheumatology and more boldly into therapeutic areas such as ophthalmology and diabetes care.
Kathy Oubre, MS
February 4th 2022

Kathy Oubre: How Biosimilars Have Helped Reduce Financial Toxicity in Cancer Care

Skylar Jeremias
Kathy Oubre, MS, chief operating officer of Pontchartrain Cancer Center, talks about how biosimilars have been able to help patients avoid financial toxicity related to oncology care costs.
vials
February 3rd 2022

Mandatory Biosimilar Switch in Canada Has Minimal Impacts on Patient Health

Laura Joszt, MA
The Biosimilars Initiative in British Columbia, Canada, mandated patients with certain conditions on the province’s prescription coverage plan to switch from originator etanercept to a biosimilar.
molecules
January 28th 2022

Biogen Sells Stake in Biosimilar Venture Samsung Bioepis

Laura Joszt, MA
Biogen is selling its stake in the biosimilar joint venture to Samsung Bioepis for up to $2.3 billion after first investing in 2012.
Ryan Haumschild (top left), Sonia Oskouei (top center), CfB's Tony Hagen (top right), Madelaine Feldman (bottom left), and Sameer Awsare (bottom right)
January 26th 2022

Panelists Explore What Exactly Is Holding Up US Adoption of Biosimilars

Skylar Jeremias
Payer intervention, lack of patient savings, and confusion surrounding interchangeability are some of the many barriers standing in the way of US biosimilar uptake, with our group of panelists calling for big changes.
gavel sitting on a scale
January 21st 2022

Patents Filed a Decade Post Originator Approval Account for Most Biosimilar Patent Lawsuits

Skylar Jeremias
Researchers have found that most US patent infringement cases against biosimilar manufacturers cover patents filed over a decade after the originator product's FDA approval, leading to limits on competition among biologic drugs.
blue molecules
January 19th 2022

Trastuzumab Biosimilar Has Similar Efficacy, Safety to Reference Product in Advanced Gastric Cancer

Laura Joszt, MA
The trastuzumab biosimilar Herzuma was shown to have similar clinical efficacy and safety to the reference product in patients with HER2-positive advanced gastric cancer.
rows of vials
January 15th 2022

US Uptake of Biosimilars Remains Suboptimal and Requires Intervention

Laura Joszt, MA
Compared with the European Union, biosimilar use in the United States lags, and the US government, health systems, and medical associations all have a role to play.
woman who is out of focus except for her eye
January 12th 2022

Ophthalmology Biobetters and Biosimilars May Be Just Around the Corner

Skylar Jeremias
More biobetter drugs may be on the horizon, with an opportunity to snatch market share from reference products, and several biosimilars are under development for ophthalmic conditions, authors of a review concluded.
Approvals, Policy Changes Raise Profile of Biosimilars in Canada
January 4th 2022

Approvals, Policy Changes Raise Profile of Biosimilars in Canada

Tony Hagen
At least 8 biosimilars were approved in Canada over the past 12 months, as policy makers made a strong push for biosimilar acceptance, which led to a change in prescribing patterns.
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January 3rd 2022

Projected US Savings From Biosimilars, 2021-2025

Andrew Mulcahy, PhD, MPP Christine Buttorff, PhD Kenneth Finegold, PhD Zeid El-Kilani, MPP Jon F. Oliver, PhD Stephen Murphy, PhD Amber Jessup, PhD
Projected savings from biosimilars from 2021 to 2025 were $38.4 billion vs conditions as of quarter 4 of 2020 and were driven by new biosimilar entry. Savings were $124.5 billion under an upper-bound scenario.
Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval
December 26th 2021

Yusimry, the Seventh Adalimumab Biosimilar, Gains FDA Approval

Laura Joszt, MA
Despite being the seventh adalimumab biosimilar approved in the United States, there are none on the market yet.
Top biosimilars articles
December 22nd 2021

Top 5 Most-Read Biosimilars News of 2021

Laura Joszt, MA
This year the United States only approved 2 biosimilars, but the FDA did grant interchangeable status to the first biosimilar.
No Easy Path to Market for Alvotech's Adalimumab Biosimilar
December 20th 2021

No Easy Path to Market for Alvotech's Adalimumab Biosimilar

Tony Hagen
In hopes of protecting its lucrative adalimumab (Humira) franchise, AbbVie is mounting a hefty legal defense against Alvotech's adalimumab biosimilar candidate.
Findings Are Reported From De-Escalation Therapy in Early Breast Cancer
December 15th 2021

Findings Are Reported From De-escalation Therapy in Early Breast Cancer

Tony Hagen
Investigators said pathologic complete response was higher with a molecularly selected subgroup of patients with early-stage breast cancer treated with a nonchemotherapy combination that included a trastuzumab biosimilar.
Surveys Probe Biosimilars in Oncology
December 13th 2021

Surveys Probe Biosimilars in Oncology

Tony Hagen
Recent surveys shed light on oncologist and patient perceptions of the switch to biosimilars and patient mental health.
Investigators Estimate Cost of Extending HER2-Directed Therapy With Biosimilars in British Columbia
December 8th 2021

Investigators Estimate Cost of Extending HER2-Directed Therapy With Biosimilars in British Columbia

Tony Hagen
Costs of extending human epidermal growth factor receptor 2 (HER2) therapy for patients with metastatic breast cancer were estimated in a retrospective study.
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