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Abbreviated Biologics Pathway Could Revive Biosimilar Competition

By Sabrina McCrear

August 19th 2026

An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.

"Biosimilar" written in wooden letter tiles | Image Credit: lexiconimages - stock.adobe.com

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

By Brooke McCormick

August 6th 2026

Biosimilars Round Up: July 2026

Biosimilars Round Up: July 2026

By Sabrina McCrear

August 4th 2026

US capitol | Image credit: W.Scott McGill - stock.adobe.com

Biosimilar Bills Gain Steam in Congress, But Key Reforms Still Wait

By Skylar Jeremias

July 23rd 2026

glp-1 | Image credit: zimmytws - stock.adobe.com

FDA Accepts Sandoz Generic Tirzepatide Applications Amid Biosimilar Development Gap

By Skylar Jeremias

July 13th 2026

More News

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

Policy Briefing Calls for More Efficient Biosimilar Approval Process

March 27th 2017

Amgen Gains EC Approval for Biosimilar to Adalimumab

Surabhi Dangi-Garimella, PhD

March 24th 2017

Amgen Files for EU Approval of Its Herceptin Biosimilar for Breast Cancer

Amgen Files for EU Approval of Its Herceptin Biosimilar for Breast Cancer

March 22nd 2017

Congressional Hearing on FDA User Fees Tackles Issues Affecting Biosimilar Approvals

March 20th 2017

Trump Administration Budget Blueprint Comes With Major Cuts to Health and Science

March 17th 2017

Dupilumab Improves Signs and Symptoms of Atopic Dermatitis Without Safety Issues

The Center for Biosimilars Staff

March 16th 2017

Greater Transparency at FDA Would Bring More Biosimilars to Market, Experts Say

Greater Transparency at FDA Would Bring More Biosimilars to Market, Experts Say

March 16th 2017

Dr Scott Gottlieb, Trump's FDA Pick, a Consistent Supporter of Biosimilar Innovation

Christina Mattina

March 14th 2017

Mylan's Settlement With Genentech and Roche Opens US Market for Trastuzumab Biosimilar

Surabhi Dangi-Garimella, PhD

March 14th 2017

European Industry Groups Urge Caution on Biosimilar Switching

European Industry Groups Urge Caution on Biosimilar Switching

March 10th 2017

Amgen Lawsuit Against Coherus Alleges Misappropriation of Neulasta Trade Secrets

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