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

Juvenile arthritis awareness month | Image credit: Ocha Designs – stock.adobe.com

Adalimumab, Etanercept Biosimilars Deliver Real-World Results for Juvenile Idiopathic Arthritis

By Hayden E. Klein

July 29th 2025

Real-world data suggest anti-TNF biosimilars for juvenile idiopathic arthritis offer comparable efficacy and safety to their brand name counterparts.

Clinician holding piggy bank | Image Credit: Dee Karen - stock.adobe.com

Oncology Biosimilars Offer Potential Relief From Financial Burden of Cancer Care

By Brooke McCormick

June 2nd 2025

FDA Approved. | Image Credit: wladimir1804 - stock.adobe.com

FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt

By Cameron Santoro

March 4th 2025

FDA Approved. | Image Credit: Nirusmee - stock.adobe.com

First Insulin Aspart Biosimilar Receives FDA Approval

By Cameron Santoro

February 20th 2025

Osteoporosis. | Image Credit: Nisit - stock.adobe.com

Denosumab Biosimilars Approved With Interchangeability to Address Osteoporosis, Fracture Risk

By Cameron Santoro

February 18th 2025

Continuing Medical Education

August 18th 2025

The Economics of Transthyretin-Mediated Amyloidosis: Balancing Equity and Access in Resource Allocation

1 Credit / Cardiology, Neurology

August 18th 2025

New and Approved: FDA’s 2024 Drug Lineup

1.5 Credits / General Pharmacy

August 18th 2025

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

2.0 Credits / General Pharmacy

August 18th 2025

Advancing Immunotherapy in Endometrial Cancer: A Managed Care Perspective on Personalized Care

1.5 Credits / Gynecologic Cancer, Health Equity, Diversity & Inclusion, Oncology, Women's Health

More News

April 19th 2016

What We're Reading: Theranos Now Subject of a Criminal Investigation

What we're reading, April 19, 2016: blood-testing laboratory Theranos is now facing a criminal investigation; biosimilars may not be cheaper than brand name biologics for some seniors; and stigma and misconceptions remain regarding palliative care.

Dr Jeremy Schafer Discusses the Importance of Immunogenicity of Biosimilars

April 19th 2016

Dr Jeremy Schafer Discusses the Importance of Immunogenicity of Biosimilars

The FDA recently approved the biosimilar infliximab and found that from an immunogenicity profile it was more or less similar, which is important for payers and providers, explained Jeremy Schafer, PharmD, MBA, vice president and director of specialty solutions at Precision For Value.

April 15th 2016

Industry Insight on the Challenges With Developing and Adopting Biosimilars

Surabhi Dangi-Garimella, PhD

Pharmaceutical industry experts provide an overview of the highly complex biosimilar development process at The Community Oncology Conference: Innovation in Cancer Care, held in Orlando, Florida.

April 13th 2016

Adoption of Biosimilars: Prescribers, Pharmacy and Payer Perspectives

April 1st 2016

NCCN Has Faith in the Potential of Biosimilars

Surabhi Dangi-Garimella, PhD

While these "generic" biologicals have been deemed to have the potential to create competition and result in healthcare savings-although not to the extent of generic products-technical issues with manufacturing these products have troubled drug manufacturers.

Dr Pamela Becker Says the US Is "Just Scratching the Surface" for Biosimilars

April 1st 2016

Dr Pamela Becker Says the US Is "Just Scratching the Surface" for Biosimilars

Now that 1 biosimilar has made it to market in the United States, Pamela S. Becker, MD, PhD, professor of medicine in the Division of Hematology at the University of Washington School of Medicine, expects more to follow and that, hopefully, biosimilars will help achieve cost savings for healthcare.

March 31st 2016

IMS Health Predicts Significant Growth of Biosimilars by 2020

Surabhi Dangi-Garimella, PhD

According to IMS Health, increased penetration and acceptance of biosimilars in Europe and in the United States can result in $110 billion in total savings to the 2 healthcare systems.

March 17th 2016

Biosimilars Important in Management of Neutropenia

Recent analysis supports the potential importance of using biosimiliars of granulocyte colony stimulating factor to manage neutropenia affecting post-chemotherapy and post-op patients.

February 18th 2016

What We're Reading: Some Clinical Trial Results Are Never Disclosed

What we're reading, February 18, 2016: one-third of clinical trial results are never published; Sandoz challenges rule for notices of biosimilar launches; and hepatitis C combination drug could reduce treatment to just 4 weeks.

February 5th 2016

A New Biosimilar to Remicade in the Fray

Scientists at the FDA have provided their recommendation to be submitted to an independent medical advisory panel that will decide the fate of Remsima.

January 8th 2016

What We're Reading: Report Reveals Full ACA Enrollment So Far

What we're reading, January 8, 2016: HHS releases report with full Obamacare enrollment information for all 50 states and the District of Columbia; the expansion of the biosimilars in 2016; and promising Ebola treatment found not effective.

January 1st 2016

5 Things to Know About Biosimilars in the New Year

Surabhi Dangi-Garimella, PhD

An update on where the field of biosimilars currently stands.

December 28th 2015

Post Test: Clinical and Managed Care Implications of Biosimilars: Evaluating the Science and Challenges to Uptake

December 22nd 2015

Top 10 Articles from Evidence-Based Oncology for the Year 2015

Surabhi Dangi-Garimella, PhD

The most read articles in The American Journal of Managed Care's Evidence-Based Oncology ranged from personal narratives to healthcare policy issues that impact the broader population.

Dr Joe V. Selby on Biosimilar Research

November 26th 2015

Dr Joe V. Selby on Biosimilar Research

The Patient-Centered Outcomes Research Institute (PCORI) will approach biosimilar research the way it does research on anything else, but there is the added element of finding the right timing, said Joe V. Selby, MD, MPH, executive director of PCORI.

October 15th 2015

What We're Reading: Biosimilar Reimbursement and Scrutinizing Drug Pricing

What we're reading, October 15, 2015: federal prosecutors subpoena Valeant Pharmaceuticals over how the company prices drugs, Atul Gawande, MD, makes the case for better coordinated care, and proposed biosimilar reimbursement sparks outrage.

Dr Amy Davidoff Highlights the Benefits of Palliative Care, Discusses Biosimilars

September 28th 2015

Dr Amy Davidoff Highlights the Benefits of Palliative Care, Discusses Biosimilars

Palliative care should enter into the discussion with patients with cancer as early as possible as it can manage symptoms from therapy or it can provide comfort to patients who cannot afford or choose to forgo therapy, said Amy Davidoff, PhD, MS. Plus, she discusses the impact biosimilars may have on therapy costs.

August 28th 2015

FDA Issues Guidance for Naming Biosimilars

Laura Joszt, MA

With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.

August 26th 2015

As Date for First Biosimilar to Hit the Market Draws Close, Reimbursement Remains Fuzzy

Surabhi Dangi-Garimella, PhD

The Biosimilars Council wants CMS to hold back on Medicare Part B reimbursement for biosimilars.

June 5th 2015

Zarxio Yet to See Light of Day in US Market

Surabhi Dangi-Garimella, PhD

A US appeals court has blocked Novartis from selling the first biosimilar to be approved in the United States.

June 4th 2015

The Biosimilar War Is Not Over Yet

Will Sandoz' biosimilar, first ever in the US, ever see the light of day?

May 14th 2015

FDA Provides New Guidance to Manufacturers on Biosimilars

While the marketing of the first biosimilar to be approved in the US market, Zarxio, has been delayed due to a court order, the FDA is providing guidance to manufacturers to help them effectively navigate the process of product development.

April 11th 2015

Biosimilars Await Naming Guidance From FDA

Sandoz's biosimilar will be sold under the trade name Zarxio but the FDA has held off on releasing a naming policy for biosimilars, giving the product a "placeholder nonproprietary name" of "filgrastim-sndz."

Key Specialty Pharmaceutical Market Trends

April 9th 2015

Key Specialty Pharmaceutical Market Trends

Laura Joszt, MA

In a session at AMCP's 27th Annual Meeting & Expo that was so popular that attendees were being directed to an overflow room, Aimee Tharaldson, PharmD, senior clinical consultant in emerging therapeutics at Express Scripts, highlighted specialty pharmaceuticals that are currently in development and expected to come to the market in the next few years.

The Lines Are Blurring in Healthcare

April 9th 2015

The Lines Are Blurring in Healthcare

Laura Joszt, MA

Trends in healthcare are driven by innovation, which is largely being driven by specialty innovation, Douglas M. Long, MBA, vice president of industry relations at IMS Health, said during the headline session "Marketplace Trends" at the Academy of Managed Care Pharmacy's 27th Annual Meeting & Expo.

March 31st 2015

Amgen Fails to Block Sandoz' Neupogen Biosimilar, Again

The battle is being closely watched for signs that brand-name drug makers may be able to delay the introduction of biosimilars, which are cheaper versions of brand-name biologics.

March 20th 2015

Novartis/Sandoz Clear to Market Their Biosimilar Zarxio

Zarxio was approved earlier this month, the first biosimilar to be approved in the United States.

March 10th 2015

Amgen Plans for Up to 5 Biosimilars by 2019

At a state-of-the-art facility in Thousand Oaks, California, drugmaker Amgen Inc. is perfecting the art of copying others, and it must work fast because copycats are already coming for Amgen's drugs.

February 16th 2015

Surabhi Dangi-Garimella, PhD

November 4th 2014

Biosimilars a Big Cost Saver, RAND Study Finds

The study by Andrew Mulcahy, a policy researcher at the RAND Corporation, found that the predicted $44 billion saving to the US healthcare system over the next decade, would depend on FDA decisions on newer biosimilar drug candidates.

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