Dermatology

Posters presented at the Academy of Managed Care Pharmacy (AMCP) eLearning Days meeting this week from April 20 to 24 reveal important data on biosimilar utilization management, switching, and affordability.

The Danish medical system saved 82.8% on adalimumab by switching almost all patients from the reference product to biosimilars, but such a benefit for the US healthcare system may not be possible, according to a new study.

With positive phase 1 study results and a manufacturing process that may cut costs significantly, BiosanaPharma hopes its omalizumab biosimilar candidate will have an edge on the worldwide market.

NeuClone said phase 1 patient monitoring and blood sampling has been completed for its ustekinumab biosimilar candidate, which is targeted at the $6.6 billion in annual revenue earned by Stelara, a Janssen Pharmaceutical Companies product.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.

Lichen planopilaris (LPP) is a type of scarring hair loss that occurs when lichen plaus, a relatively common inflammatory skin disease, affects areas of skin where hair grows. It destroys the hair follicle and replaces it with scarring, resulting in permanent hair loss. LPP’s causes and pathology are unknown.

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.

The review found no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy. Overall, however, patients with psoriasis appear to have a slightly increased risk of certain cancers.

The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.

Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.

Could adalimumab and its biosimilars become a less attractive option for treating some inflammatory diseases in the face of new therapeutic choices like interleukin-17 inhibitors? In the case of ixekizumab, a recent head-to-head study versus adalimumab showed that the newer product was superior in terms of improving joint and skin disease in patients with psoriatic arthritis.

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

There is increasing evidence to suggest that therapeutic drug monitoring (TDM) will allow for more tailored and rational use of biologics in psoriasis.

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

A recent study found no difference in the risk of developing atrial fibrillation (AF) or major adverse cardiovascular events (MACE) associated with ustekinumab versus anti–tumor necrosis factor (anti-TNF) therapy in patients with psoriasis or psoriatic arthritis.

Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).

Given the cost of the brand-name drug, there is interest among providers, particularly in contexts with limited resources, in using a biosimilar rituximab to treat pemphigus, and recently, 2 studies reported on the use of biosimilar rituximab in treating this disease.

Treatment with the biosimilar, the investigators concluded, resulted in comparable, maintained quality of life improvements that were not impacted by a switch from the reference product.

Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.

This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.

The approval comes as welcome news for AbbVie, which seeks to strengthen its immunology sales as it faces biosimilar competition for its flagship therapy, adalimumab (Humira).

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.

The European Commission has approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union, and the first major new therapeutic option in 60 years.