|Name/Company||Approval Dates and Comments|
Adalimumab-adbm for SC injection
In August 2017, the US FDA approved a biosimilar to Humira® (adalimumab, AbbVie), in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including active psoriatic arthritis and moderate-to-severe plaque psoriasis. For psoriatic arthritis Cyltezo™ is indicated, alone or in combination with nonbiologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. For plaque psoriasis Cyltezo™ is indicated for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
In August 2017, the European Commission (EC) approved Imraldi®, a biosimilar referencing Humira® (adalimumab, AbbVie), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, and uveitis. With the EC’s marketing authorization of Imraldi®, Samsung Bioepis becomes the first in the industry to receive European approvals for biosimilars referencing all three anti-TNF-alpha biologic agents; Benepali® (etanercept) and Flixabi® (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively. The EC approval of Imraldi® applies to all 28 European Union (EU) member states, as well as the European Economic Area (EEA) member states.
The FDA granted Breakthrough Therapy designation status to cemiplimab, a fully human monoclonal antibody, in September 2017 for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC – considered to be the second deadliest skin cancer after melanoma. Cemiplimab is a checkpoint inhibitor targeting the programmed death receptor 1 (PD-1). The regulatory decision was based on positive, preliminary results for cemiplimab from two expansion cohorts involving 26 advanced CSCC patients in a Phase 1 study of nearly 400 patients. Treatment with cemiplimab led to an overall response rate (ORR) of 46.2% and a disease control rate of 69.2%. A Phase 2, single-arm, open-label clinical trial, EMPOWER-CSCC 1, is currently enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.
In September 2017, Health Canada approved migalastat, a firstin- class oral, small molecule, precision therapy for the long-term treatment of adults with a confirmed diagnosis of Fabry disease [deficiency of alpha-galactosidase (alpha-Gal A)] and who have an alpha-Gal A mutation determined to be amenable by an in vitro assay.
Secnidazole oral granules
The FDA approved secnidazole 2g oral granules in September 2017 for the treatment of bacterial vaginosis (BV) in adult women. Secnidazole is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Secnidazole is the first and only single-dose oral therapy for BV.