Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

Development 161

Development Production Immune Response Licensing 161

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. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. 10% of patients 1.

Trials 52

Trials Medicine Production Containment 52

XTalks

FEBRUARY 8, 2021

They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. The regulator allows biosimilars to show slight differences in clinically inactive components of a product. What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78