USP Drops Biologics Naming Proposal
After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.
On April 27, 2018, the US Pharmacopeial Convention (USP) announced it was not moving forward with its biologics naming proposal, General Notices Section 2.20, published in the Pharmacopeial Forum, and it will not address nomenclature issues without further collaboration with FDA and other stakeholders. The decision was made in response to comments received by FDA.
USP stated in a press release that it will focus on developing performance standards applicable to monoclonal antibodies or cell therapies and developing standards for raw materials. The organization will also work to “ensure alignment with FDA on the use of the term ‘with sensor’ in approved product names, for drug therapies with sensor technology that verifies when a patient has taken their medication.”
“USP's biologics performance standards can help manufacturers ensure the quality of their products and are part of the overall safety net that helps protect our medicine supply in the United States,” said Jaap Venema, PhD, chief science officer, in the release.
Source: USP
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.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
