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Global health care access. | Image Credit: hamkin - stock.adobe.com.jpeg

Global Data Show Variety in Adalimumab Biosimilar Design, Patient Support Systems

By Skylar Jeremias

November 7th 2025

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

FDA website and updates on biosimilar reforms | Image credit: Postmodern Studio - stock.adobe.com

A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development

By Skylar Jeremias

October 30th 2025

laboratory and biosimilar development | Image credit: Cavan - stock.adobe.com

BioRationality: The FDA Sets Sights on Removing Clinical Efficacy Studies for Biosimilars

By Sarfaraz K. Niazi, PhD

October 29th 2025

FDA approves Celltrion aflibercept biosimilar | Image credit: Tada Images - stock.adobe.com

FDA Approves Celltrion Aflibercept Biosimilar: Eydenzelt

By Skylar Jeremias

October 13th 2025

CFB eye on pharma banner

Eye on Pharma: Europe and MENA Region See Expanding Biosimilar Pipelines

By Skylar Jeremias

September 25th 2025

More News

Legal Battles Over the Biosimilars Patent Dance Continue in Amgen v Hospira

The ongoing district court litigation of Amgen v Hospira—a case regarding Hospira’s proposed biosimilar to epoetin alfa (Epogen), a biological agent used to treat anemia—progressed on May 26, 2017, when counsel for Amgen filed a motion for a preliminary injunction.

Comments on the FDA's Biosimilar Interchangeability Draft Guidance Highlight a Growing Need for Clarity

Comments on the FDA's Biosimilar Interchangeability Draft Guidance Highlight a Growing Need for Clarity

FDA Commissioner Gottlieb Will Work in a Variety of Ways to Contain Drug Prices

FDA Commissioner Gottlieb Will Work in a Variety of Ways to Contain Drug Prices

UK Authority: Merck Used Illegal Discounts to Defend Against Biosimilar Competition to Remicade

Christina Mattina

Pfizer's Epogen Biosimilar Called "Highly Similar" to Reference Drug

Celltrion to Play With 4 Brand Names in the EU With Rituximab Biosimilar

Janssen Moves to Block Marketing of Renflexis in Suit Against Samsung Bioepis

Janssen Moves to Block Marketing of Renflexis in Suit Against Samsung Bioepis

Surabhi Dangi-Garimella, PhD

Biopharma Companies Seek Greater Clarification About FDA's Interchangeability Guidance

AbbVie Loses Humira Patent Challenge to Coherus

Christina Mattina

Yet Another Pegfilgrastim Biosimilar Candidate Announces Positive Clinical Study Data

Senate Confirms Scott Gottlieb as FDA Commissioner

Surabhi Dangi-Garimella, PhD

Celltrion Plans Filing for Biosimilars to Rituximab, Trastuzumab

Biosimilars at the Gates: What's Ahead?

Biosimilar Uptake Implies Patient Access to Affordable Medication

The Center for Biosimilars Staff

April 28th 2017

Who Will Influence Biosimilar Uptake: Physician, Pharmacist, Patient, or Payer?

Who Will Influence Biosimilar Uptake: Physician, Pharmacist, Patient, or Payer?

April 27th 2017

Proposed Xolair Biosimilar Gets FDA Approval for Clinical Trials

April 26th 2017

Advances in the Development of Ranibizumab and Teriparatide Biosimilars

April 25th 2017

EMA Recommends 9 New Medicines, Including Biosimilars

EMA Recommends 9 New Medicines, Including Biosimilars

April 25th 2017

Second Biosimilar to Infliximab Approved

Second Biosimilar to Infliximab Approved

The Center for Biosimilars Staff

April 22nd 2017

US Supreme Court to Consider Sandoz vs Amgen Biosimilar Patent Dance Case on April 26

April 21st 2017

Nebraska Legislature Debates Biosimilar Substitution Bill

Christina Mattina

April 18th 2017

In a Surprise Decision, FDA Further Delays Approval of Lilly's RA Drug

In a Surprise Decision, FDA Further Delays Approval of Lilly's RA Drug

April 16th 2017

Senate Bill Seeks to Improve Access to Affordable Rx Drugs

Senate Bill Seeks to Improve Access to Affordable Rx Drugs

April 13th 2017

Humira Not Cost Effective for RA, ICER Report Concludes

April 11th 2017

Multiple Challenges Predicted for Biosimilars in 2017

Multiple Challenges Predicted for Biosimilars in 2017

Lauren Santye, Assistant Editor, Specialty Pharmacy Times

European Drug Agency's Move Out of London, Spurred By Brexit, Could Disrupt Pipeline

Christina Mattina

Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel

Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel

Rituxan Given Breakthrough Therapy Designation for Pemphigus Vulgaris

March 30th 2017

New Drug Approved for MS, First With PPMS Indication

New Drug Approved for MS, First With PPMS Indication

March 29th 2017

Dupilumab, a Biologic Treatment for Eczema, Approved by FDA

Dupilumab, a Biologic Treatment for Eczema, Approved by FDA

March 29th 2017

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