Regulatory

Latest News

FDA Approved. | Image Credit: gguy - stock.adobe.com
FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion

January 6th 2026

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.

top 5 regulatory articles of 2025
Top 5 Most-Read Regulatory Articles of 2025

December 19th 2025

DNA syringe | Image credit: natali_mis - stock.adobe.com
Denosumab, Golimumab Biosimilars Clear Major Regulatory Milestones in Europe, as US Hurdles Remain

December 16th 2025

money vial | Image credit: digicomphoto - stock.adobe.com
BioRationality: FDA Issues New Guidance on Promotional Communications for Biosimilar Products

December 11th 2025

Bone metastases. | Image Credit: Nasr - stock.adobe.com .jpeg
FDA Quietly Approves Denosumab Biosimilars, Issues Interchangeability for Others

November 13th 2025

More News

Site Logo

Humira Not Cost Effective for RA, ICER Report Concludes

Jackie Syrop
April 11th 2017

Multiple Challenges Predicted for Biosimilars in 2017

Multiple Challenges Predicted for Biosimilars in 2017

Lauren Santye, Assistant Editor, Specialty Pharmacy Times
April 6th 2017

Site Logo

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

Christina Mattina
April 6th 2017

Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel

Nominee for FDA Commissioner Vows to Strike Balance Before Senate Panel

Jackie Syrop
April 6th 2017

Site Logo

Rituxan Given Breakthrough Therapy Designation for Pemphigus Vulgaris

Jackie Syrop
March 30th 2017

New Drug Approved for MS, First With PPMS Indication

New Drug Approved for MS, First With PPMS Indication

Jackie Syrop
March 29th 2017

Dupilumab, a Biologic Treatment for Eczema, Approved by FDA

Dupilumab, a Biologic Treatment for Eczema, Approved by FDA

Jackie Syrop
March 29th 2017

Site Logo

Policy Briefing Calls for More Efficient Biosimilar Approval Process

Jackie Syrop
March 27th 2017

Site Logo

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

Jackie Syrop
March 22nd 2017

Site Logo

Congressional Hearing on FDA User Fees Tackles Issues Affecting Biosimilar Approvals

Jackie Syrop
March 20th 2017

Site Logo

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

Jackie Syrop
March 17th 2017

Site Logo

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

Jackie Syrop
March 16th 2017

Site Logo

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

Christina Mattina
March 14th 2017

Site Logo

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

Jackie Syrop
March 10th 2017

Site Logo

Amgen Lawsuit Against Coherus Alleges Misappropriation of Neulasta Trade Secrets

Jackie Syrop
March 9th 2017

Site Logo

Siliq Approved Without a Suffix

Jackie Syrop
March 7th 2017

Site Logo

Sandoz Releases Efficacy Data for Its Humira Biosimilar

Christina Mattina
March 7th 2017

Site Logo

FDA's Director of Drug Evaluation Urges Congress to Pass the BsUFA Reauthorization

Jackie Syrop
March 4th 2017

US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections

US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections

Jackie Syrop
March 3rd 2017

Bioequivalence Endpoints Successfully Met for Humira Biosimilar, Coherus Announces

Bioequivalence Endpoints Successfully Met for Humira Biosimilar, Coherus Announces

Christina Mattina
March 2nd 2017

Site Logo

Diabetes Drugs Could Be Next Frontier of Biosimilar Development

Christina Mattina
March 1st 2017

Site Logo

Will the Biosimilars Bubble Burst Even Before It Expands?

Jackie Syrop
February 28th 2017

New Mexico Senate Passes Bill for Biosimilar Substitution

New Mexico Senate Passes Bill for Biosimilar Substitution

Surabhi Dangi-Garimella, PhD
February 28th 2017

Site Logo

FDA Should Forge Ahead on Biosimilar Drug Reviews: A Rheumatologist's Opinion

Jackie Syrop
February 27th 2017

Site Logo

Truxima Receives Approval in EU for Autoimmune, Oncology Indications

Christina Mattina
February 23rd 2017

Will US Follow UK on Managed Biosimilar Switching of IBD Patients on Infliximab?

Will US Follow UK on Managed Biosimilar Switching of IBD Patients on Infliximab?

Jackie Syrop
February 22nd 2017

Biosimilars Council Wants Elimination of 6-Month Exclusivity for Biologics

Biosimilars Council Wants Elimination of 6-Month Exclusivity for Biologics

Jackie Syrop
February 21st 2017

<1
...
464748495051>
© 2026 MJH Life Sciences

All rights reserved.