May 16th 2024
Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
In Updated Draft Evidence Report on RA, ICER Changes Course on Assessing JAK Inhibitors
October 11th 2019The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment body, has issued an updated report on treatments for rheumatoid arthritis (RA) in which it says that the Janus kinase (JAK) inhibitor upadacitinib has a marginal clinical benefit over adalimumab and an "incremental cost-utility ratio falling below commonly cited thresholds.”
Samsung Bioepis' Etanercept Biosimilar Performs in Real-World Treatment of Psoriasis
October 9th 2019In 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.
Anti-TNF Therapies Reduce Alzheimer Risk in RA, Psoriasis, Early Study Says
October 9th 2019A recent preliminary study examined whether adults treated with anti–tumor necrosis factor agents (anti-TNFs) had reduced the risk of Alzheimer disease, and found that patients with rheumatoid arthritis (RA) and psoriasis who were treated with anti-TNFs had a lower risk of developing the incurable neurocognitive disorder.
Pediatric Patients and Their Families Report Unique Concerns When It Comes to Biosimilar Switching
October 7th 2019According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.
Head-to-Head Study Shows Ixekizumab Outperforms Adalimumab in Psoriatic Arthritis
October 3rd 2019Could 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.
Novartis to Seek a Fourth Indication for Secukinumab
October 2nd 2019Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.
Celltrion Receives Positive CHMP Opinion for Subcutaneous Infliximab Biosimilar, CT-P13
September 23rd 2019During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.
AHIP Report Cites Reference Biologics as Examples of Orphan Drug Gaming
September 17th 2019While acknowledging the role that the Orphan Drug Act had in incentivizing drug companies to develop treatments for small populations suffering from rare diseases, America’s Health Insurance Plans (AHIP) says pharmaceutical companies are using orphan drug status to create blockbuster drugs that are then used to treat other common medical conditions.
Patients With Rheumatic Diseases Face Substantial Hurdles in Accessing Treatment, ACR Says
September 16th 2019While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.
Number of Prior DMARDs Could Negatively Impact Response to Anti-TNFs in RA
September 10th 2019It is already understood that a longer disease duration and delays in using disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) is associated with worse disease control, but a new study, published just last month, has shown that the number of conventional DMARDs used before starting anti–tumor necrosis factor (anti-TNF) therapy could reduce the magnitude of a patient’s response to anti-TNFs like adalimumab.
Giving Specialty Drugs Outside Hospital Settings Could Save $4 Billion Annually, Report Says
September 9th 2019A new report released Monday by UnitedHealth Group finds that administering specialty drugs—which are typically injected or infused—in homes or in independent physician offices instead of hospitals could save as much as $4 billion each year.
Across 36 RCTs, No Difference Between Reference, Biosimilar Anti-TNFs in RA Joint Destruction
September 9th 2019For patients with rheumatoid arthritis (RA), avoiding damage to cartilage and bone in the joints is a key consideration for treatment. While anti–tumor necrosis factor (anti-TNF) therapies are used to treat RA and reduce joint destruction, the available anti-TNF agents, both originator and biosimilar, have not been directly compared with one another or with placebo in terms of their impacts on joint damage. A new study, published last week, attempted to address that gap in the literature by conducting a meta-analysis of randomized controlled trials (RCTs).
When Withdrawing Etanercept, Patients With Sustained Deep RA Remission Fare Best
September 2nd 2019One recent paper analyzed data from 3 studies on down-titration of etanercept in patients with rheumatoid arthritis (RA) and concluded that patients who have achieved disease control according to a stringent definition have a greater likelihood of remaining in remission after reducing their dose or withdrawing etanercept.
IBI303 Therapeutically Equivalent to Reference Adalimumab in Ankylosing Spondylitis in Phase 3 Study
August 30th 2019Results of a phase 3 trial of IBI303, a proposed adalimumab biosimilar referencing Humira, showed that it is therapeutically equivalent in terms of efficacy, safety, and immunogenicity to the originator product, according to a study published in the first issue of The Lancet Rheumatology.
Ahead of US Biosimilar Etanercept Competition, Amgen Acquires Apremilast
August 27th 2019Amgen 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.
Fewer Than One-Third of New Patients With RA Receive Disease-Modifying Medications, Study Says
August 20th 2019Fewer than one-third of patients newly diagnosed with rheumatoid arthritis (RA) used anti–tumor necrosis factors agents, other biologics, Janus kinase inhibitors, or conventional disease-modifying antirheumatic drugs in 2014.
AbbVie Gains FDA Approval for Upadacitinib, Its Successor to Humira
August 19th 2019Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.
Biosimilar Etanercept, LBEC0101, Is Safe and Effective Up to Week 100 in RA
August 15th 2019LG Chem’s biosimilar etanercept, LBEC0101, referencing Enbrel, recently gained approval in Japan and the Republic of Korea. Among the data that led to its authorization were those deriving from a phase 3 study that demonstrated the biosimilar had equivalent efficacy and a comparable safety profile to the reference product. Recently, researchers reported on a single-arm, open-label extension study in patients with rheumatoid arthritis (RA) who completed the 52-week phase 3 study.
Fresenius Kabi's Biosimilar Adalimumab, Idacio, Is Similar to Humira in RA in Terms of Safety
August 13th 2019This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.