On February 22, 2024, Artiva announced that the FDA has granted Fast Track designation to Artiva’s AlloNK (AB-101) for the treatment of lupus nephritis in combination with rituximab or obinutuzumab. AlloNK is an allogeneic, off-the shelf, NK cell therapy that is not genetically modified and designed to enhance the antibody-dependent…
On February 16, 2024, the FDA approved Iovance’s AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma. AMTAGVI is indicated to treat adult patients with unresectable or metastatic melanoma that have previously been treated with a PD-1 blocking antibody, and if BRAF…
Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated…
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” …
Celltrion Submits BLA for Tocilizumab Biosimilar On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor antagonist indicated for adult rheumatoid arthritis, juvenile idiopathic polyarthritis, and systemic juvenile…
As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…
On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta…
On December 8, 2023, the FDA approved the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older—Vertex’s CASGEVY and Bluebird’s LYFGENIA. SCD is a group of inherited blood disorders affecting approximately 100,000 people in the U.S. and inducing a median life…
On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. AVZIZI is the fifth bevacizumab biosimilar approved by the FDA, behind Amgen’s MVASI (bevacizumab-awwb), approved in September 2017; Pfizer’s ZIRABEV (bevacizumab-bvzr), approved in June 2019; Amneal’s ALYMSYS (bevacizumab-maly), approved in…
Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA. According to the report, once CT-P41 is approved in the U.S., “it is expected to secure…