Amjevita, a Biosimilar to Humira, Now Available
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
Roflumilast foam is an investigational topical formulation of a highly potent and selective phosphodiesterase type 4 inhibitor.
The approval was granted Competitive Generic Therapy exclusivity meaning the Company will have 180 days exclusivity.
Approvals in psoriasis, hepatorenal syndrome, and neutropenia; novel therapy gains Priority Review for Rett Syndrome; and the effects of multivitamin supplementation assessed in cognitive function.
The approval was based on data from the phase 3 POETYK PSO-1 and POETYK PSO-2 trials in adults with moderate to severe plaque psoriasis.
This week, news of the FDA’s vote on AMX0035, the novel ALS treatment; CPAP and BiPAP device recalls; Orphan Drug designation for a novel CRISPR therapy; Imfinzi gains new approval; and Spevigo is approved for pustular psoriasis flares.