Antibody, Bioequivalency, Containment and Regulation

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Antibody

Bioequivalency

Containment

Regulation

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

DECEMBER 13, 2021

The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. An application submitted under 351(a), also known as a “stand-alone” application, must contain all safety and effectiveness information for a biological product and cannot depend on any other biological product.

Development

Development Production Immune Response Licensing

Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

The Pharma Data

AUGUST 5, 2020

About ofatumumab Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) in development for RMS that is self-administered by a once-monthly injection, delivered subcutaneously 1,3. Novartis is committed to bringing ofatumumab to patients worldwide and additional regulatory filings are currently underway. 10% of patients 1.

Trials

Trials Medicine Production Containment

Clinical Research Informer

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

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