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

By Cameron Santoro

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

By Jingjing Qian, PhD

December 16th 2024

Seattle Washington skyline | Image Credit: © espiegle - stock.adobe.com

From Approval to Practice: Addressing the Hurdles in Biosimilar Integration

By Skylar Jeremias

December 12th 2024

Health Policy. | Image Credit: Mohamad Zaki - stock.adobe.com

Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

By Cameron Santoro

December 4th 2024

FDA approval. | Image Credit: syahrir - stock.adobe.com

FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

By Skylar Jeremias

December 2nd 2024

More News

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.

August 27th 2014

Joe Jimenez, Novartis CEO, Doesn't Expect An Early Impact of Biosimilars

Sandoz, the companies generics unit, recently submitted an application with the US FDA for approval of it's biosimilar filgrastim; it's the first-ever biosimilar application with the FDA.

August 22nd 2014

Health Blog: The Evolving Biosimilars Market

With the FDA accepting an application from Sandoz for it's biosimilar filgrastim, the biosimilar landscape in the US is expected to undergo a huge turnaround.

August 5th 2014

Senators Enquire on Policy for Biosimilars

Within a week of Sandoz applying for approval of it's biosimlar to Amgen's Neupogen, U.S. senators want the FDA to lay down guidelines on naming these drugs.

July 7th 2014

What's in a Name — FDA Urged Not to Give Biosimilars Unique Names

This week, a coalition of 32 major pharmacies, health insurers, unions and pension plans asked the FDA not to require distinct names for biosimilar medications, arguing that such a move would not compromise patient safety, but could undermine the savings that are expected to be generated as these medicines are introduced into the US health care system.

November 5th 2012

UnitedHealthcare Bars Copay Coupons for Specialty Drugs

According to a report by Elsevier's BusinessIntelligence, UnitedHealthcare has announced that pharmacies that are participating in its Designated Specialty Pharmacy network will no longer redeem manufacturer-sponsored coupons as an offset to member cost-sharing payments for 6 specialty drugs beginning January 1, 2013.

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