FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, nonclinical, and clinical considerations.
“This guidance focuses on a range of regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Of note, many aspects of a bispecific antibody development program will be similar to monoclonal antibody development programs. This guidance discusses unique aspects for chemistry, manufacturing, and controls (CMC), as well as nonclinical and clinical development programs for bispecific antibodies. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody development program,” the guidance document states.
The guidance may also apply to the development of other bispecific protein products and multispecific products but does not discuss antibody cocktails, polyclonal antibody products, or combinations of monoclonal antibodies.
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
