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FDA Approves Ranibizumab-hkdz as First Interchangeable, Available in Both Vials and Prefilled Syringes

By Cyrus Karkaria, PhD

June 17th 2026

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

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FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

By Kennedy Ferruggia

June 8th 2026

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Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

By Skylar Jeremias

March 10th 2026

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FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

By Skylar Jeremias

March 9th 2026

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Eye on Pharma: Global Approvals, Launches, and Strategic Partnerships

By Skylar Jeremias

January 12th 2026

More News

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

Siliq Approved Without a Suffix

Sandoz Releases Efficacy Data for Its Humira Biosimilar

Christina Mattina

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

US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections

US and EU Agree on Mutual Recognition of Drug Manufacturing Inspections

Bioequivalence Endpoints Successfully Met for Humira Biosimilar, Coherus Announces

Bioequivalence Endpoints Successfully Met for Humira Biosimilar, Coherus Announces

Christina Mattina

Diabetes Drugs Could Be Next Frontier of Biosimilar Development

Christina Mattina

Will the Biosimilars Bubble Burst Even Before It Expands?

February 28th 2017

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