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

Retinal condition | Image Credit: Yakobchuk Olena - stock.adobe.com

Biosimilar Aflibercept P041 as Effective, Safe as Originator in nAMD

By Cameron Santoro

October 30th 2024

Biosimilar aflibercept (P041) demonstrated comparable safety and efficacy to the originator aflibercept (Eylea) in treating patients with retinal conditions like neovascular age-related macular degeneration (nAMD).

health policy chart | Image credit: JOURNEY STUDIO7 - stock.adobe.com

Exploring the Complexities of Biosimilars and Interchangeability

By Skylar Jeremias

October 30th 2024

Cost of health care | Image Credit: Scott Hales - stock.adobe.com

Biosimilars Expand Access and Reduce Costs in Oncology, Immunology

By Cameron Santoro

October 28th 2024

Market share increase | Image Credit: Kiattisak - stock.adobe.com

Samsung Bioepis Reports 2024 Biosimilar Market Growth Trends

By Cameron Santoro

October 15th 2024

FDA approve graphic on screen over a doctor | Image credit: wladimir1804 - stock.adobe.com

FDA Approves Imuldosa, a Fifth Biosimilar to Stelara

By Skylar Jeremias

October 11th 2024

Continuing Medical Education

October 30th 2024

Managed Care Pharmacy: A Plan for the Future and How Pharmacists Are Leading the Way

0.5 Credits / General Pharmacy

More News

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.

October 31st 2012

Industry Voices: Biosimilars and Trade Secrets

Trade secrets may potentially be used to protect manufacturing processes for biological drugs--yet there is concern that the new law on biosimilars, the BPCIA (Biologics Price Competition and Innovation Act of 2009), and the accompanying FDA regulations, may expose trade secrets of both originators and biosimilar applicants.

October 5th 2012

VIDEO: Aimee Tharaldson, PharmD, Discusses the Impact of Biosimilars on the Specialty Pharmacy Market

In this video, Aimee Tharaldson, PharmD, Senior Clinical Consultant, Emerging Therapeutics Express Scripts, Inc, talks about the impact that biosimilar medications could potentially have on the specialty pharmacy market.

The Challenges in Manufacturing Biologics [Video]

August 22nd 2012

The Challenges in Manufacturing Biologics [Video]

This content is brought to you by Amgen This video summarizes the complex process of creating biologics from start to finish and describes some of the unique challenges-- and tremendous effort-- involved in delivering safe and effective biologics.

August 20th 2012

Considerations for the Development and Manufacturing of Biosimilars [Presentation]

August 18th 2012

Biosimilars: Overview of Legislation, Policy, and Current State of Implementation

August 18th 2012

COMING SOON: Biosimilars: Overview of the FDA Draft Guidance Documents [Presentation]

March 12th 2012

Deciphering the Impact of Generic Drugs on Healthcare Costs

With so many factors at play, it can be difficult to assess the true impact of generic drugs on healthcare costs.

October 3rd 2011

A False Start on Biosimilar Savings?

As the FDA continues to work on the biosimilars approval process, there are growing concerns that a true cost-savings can't be realized.

Study Documents How Price of TNF Inhibitors Rose After New Competition

January 1st 2003

Study Documents How Price of TNF Inhibitors Rose After New Competition

Allison Inserro

A study of cost trends for tumor necrosis factor (TNF) inhibitors for rheumatoid arthritis (RA) after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose by $17,390. Taxpayer funds shouldered all of the increases, and the “findings illustrate a market failure contributing to the rising costs of prescription drugs,” according to the researchers.

Study Documents How Price of TNF Inhibitors Rose After New Competition

January 1st 2003

Study Documents How Price of TNF Inhibitors Rose After New Competition

Allison Inserro

A study of cost trends for tumor necrosis factor (TNF) inhibitors for rheumatoid arthritis (RA) after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose by $17,390. Taxpayer funds shouldered all of the increases, and the “findings illustrate a market failure contributing to the rising costs of prescription drugs,” according to the researchers.

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