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.
Diagnosis & Disease Information
December 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
FDA Accepts Resubmitted BLA for Bimekizumab for Plaque Psoriasis
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
Idacio, a Citrate-Free Biosimilar to Humira, Gets FDA Approval
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 Effective for Scalp, Body Psoriasis in Phase 3 Trial
Roflumilast foam is an investigational topical formulation of a highly potent and selective phosphodiesterase type 4 inhibitor.
First Generic Versions of Tazorac Gel Get FDA Approval
The approval was granted Competitive Generic Therapy exclusivity meaning the Company will have 180 days exclusivity.
MPR Weekly Dose Podcast Episode #131
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.
FDA Approves Sotyktu for Moderate to Severe Plaque Psoriasis
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.
MPR Weekly Dose Podcast #130
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.
