NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials. But the drug – which would cost over $104,000 per year for the weekly injections used in the…
Search results for: Humira
FDA Panel Backs Amgen Biosimilar of Humira
(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…
FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira
(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…
U.S. Patent Office Rules Against Amgen Humira Challenge
(Reuters)—U.S. patent officials on Thursday denied petitions by Amgen to review two formulation patents on AbbVie’s Humira (adalimumab), a potential setback in Amgen efforts to market a biosimilar version of the world’s top-selling prescription medicine. In June, Amgen, the world’s biggest biotechnology company, asked the U.S. Patent and Trademark Office for the review, arguing that…
FDA Proposal for Biosimilar Use in 2025 Budget
A proposal for biosimilar use in the 2025 budget would allow substitution of any biosimilar for its reference product without an interchangeable designation. The hope is to increase biosimilar uptake, with the subsequent potential to increase product “competition, access and affordability.”1 In the 2025 budget proposal, the Biden administration noted that the legal distinction between…
Beyond the Clinic: Lessons Learned from a Rheumatologist with RA
A pediatric rheumatologist diagnosed with RA following the birth of her first child talks about integrative care & offers tips for helping patients reduce the symptom burden.
Marching to the Biosimilar Beat: Questions on Rollout Remain
The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.
JAK Inhibitors vs. TNF Inhibitors: Understanding Infection Risks
Research from Choi et al. provides insights into the risk of infection in patients with rheumatoid arthritis (RA), comparing patients treated with Janus kinase inhibitors vs. tumor necrosis inhibitors. The most frequent infection was herpes zoster, with patients treated with JAK inhibitors having a significantly greater risk of herpes zoster infection than those treated with TNF inhibitors.
Psoriatic Arthritis Drugs at a Glance, 2023
Biosimilars have become a therapeutic turning point for many patients who are living with rheumatic illnesses. Psoriatic arthritis (PsA) is a complex, multi-faceted chronic inflammatory musculoskeletal and skin disease where the treatment has changed considerably over the past few years. Psoriatic arthritis has an impact on about 30% of people with psoriasis.1 In 2019, the…
How the U.S. Will Set Up New Medicare Drug Price Talks
WASHINGTON—The U.S. government will soon begin hiring experts and collecting the data needed to launch direct negotiations over prescription drug prices for older and disabled people, a top Biden administration official told Reuters. President Joe Biden last week signed into law the Inflation Reduction Act, introducing new policies to tackle climate change, taxes and the…
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