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

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

December 16th 2024

Seattle Washington skyline | Image Credit: © espiegle - stock.adobe.com
From Approval to Practice: Addressing the Hurdles in Biosimilar Integration

December 12th 2024

Health Policy. | Image Credit: Mohamad Zaki - stock.adobe.com
Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

December 4th 2024

FDA approval. | Image Credit: syahrir - stock.adobe.com
FDA Approves Sixth Ustekinumab Biosimilar, Yesintek

December 2nd 2024

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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.
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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.
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August 20th 2012

Considerations for the Development and Manufacturing of Biosimilars [Presentation]

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August 18th 2012

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

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August 18th 2012

COMING SOON: Biosimilars: Overview of the FDA Draft Guidance Documents [Presentation]

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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.
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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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January 1st 2000

Suzette Kox, MPharm: Shared Biosimilar Challenges in the United States and Europe

Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses challenges faced jointly by the US and EU biosimilars markets.
Advisory Council Supports Biosimilars in Call for Universal Public Drug Coverage in Canada
January 1st 2000

Advisory Council Supports Biosimilars in Call for Universal Public Drug Coverage in Canada

Allison Inserro
A Canadian advisory council is recommending the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a $15.3 billion (approximately US $11,408,521,500) universal, single-payer, public system for pharmaceutical coverage.
Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form
January 1st 2000

Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form

Allison Inserro
Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the Annual European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).
ACR Supports Continued Use of Telemedicine and Reimbursement Parity After COVID-19 Crisis
December 1st 1997

ACR Supports Continued Use of Telemedicine and Reimbursement Parity After COVID-19 Crisis

Laura Joszt, MA
The widespread adoption of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, as well as reimbursement parity that was enacted by CMS, should be continued once the public health emergency passes, according to a new position statement by the American College of Rheumatology (ACR).
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