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FDA Approval
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Big Molecule Watch
FDA Approves First Interchangeable Biosimilars to Simponi and Simponi Aria; Janssen Seeks a Preliminary Injunction to Block Their Launch
By Sarah Adam
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI (golimumab-sldi) as an…
Big Molecule Watch
FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept)
By Sam Herron
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related…
Big Molecule Watch
FDA Accepts Dr. Reddy’s Laboratories’ BLA for Abatacept Biosimilar
By Emma Murray
Dr. Reddy’s Laboratories (“Dr. Reddy’s”) announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb’s ORENCIA® (abatacept) IV for infusion. According…
Health Law Informer
FDA Announces New Approval Pathway for Drugs Treating Ultra-Rare Diseases
On February 23, the FDA announced a new approval pathway designed to support the development of drugs for ultra-rare diseases. Often, treatments for ultra-rare diseases have difficulty meeting the agency’s…
Big Molecule Watch
Celltrion and Sandoz Launch Their Aflibercept Biosimilars in Europe
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all indications approved…
Substance Law Blog
Drug Identification Numbers (DINs) in Canada
By Publisher
What is a Drug Identification Number (DIN)? The Purpose of a DIN A Drug Identification Number, or DIN, is a unique eight-digit code assigned by Health Canada to drug products…
Spicy IP
Data Exclusivity Debate Resurfaces Amidst US-FTA Talks, Evidence Still Missing
(Long post ahead!) A Central Drugs Standard Control Organization (CDSCO) notice has triggered fresh discussions on a data exclusivity regime for pharmaceutical products in India. The notice dated October 8…
Big Molecule Watch
European Commission Approves Alvotech’s and Teva’s Denosumab Biosimilars
By Sarah Adam
On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is…
Boston Accident Lawyer Blog
How New Mental Health Treatments Get Approved: Does The Current System Work?
Turn on your TV, and you’re likely to be bombarded with slick ads promoting “the latest” in new drugs and drug devices to treat a variety of illnesses, diseases and…
Big Molecule Watch
FDA Accepts Sanofi and Regeneron’s Dupixent sBLA for Priority Review
By Emma Murray
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and…