ZURICH (Reuters)—Novartis said its Sandoz division received approval from the European Commission for its biosimilar Zessly (infliximab) in gastroenterological, rheumatological and dermatological diseases. Zessly is approved for use in all indications of the reference medicine including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult and pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis,…
Search results for: biosimilar
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
FDA Expands Label for Insulin Degludec; Adalimumab Biosimilar Moves Forward After Legal Battle
The FDA has expanded the label for insulin degludec to include data on improved cardiovascular outcomes and deceased severe hypoglycemia…
AbbVie, Samsung Bioepis in Deal; Humira Biosimilar U.S. Release in 2023
(Reuters)—AbbVie Inc. on Thursday said it signed a deal with Samsung Bioepis and its joint venture partner Biogen Inc. that would fend off U.S. competition of their biosimilar version to blockbuster drug, adalimumab (Humira), until 2023. This is the second deal AbbVie has signed over the past year as it tries to safeguard patents on Humira,…
The ACR Updates Biosimilar Position Statement
In March, the ACR released a white paper designed primarily to help rheumatologists and rheumatology health professionals gain an understanding of biosimilars.1 This research-based education piece examines the scientific, economic and prescribing issues related to the use of biosimilars. Now, the ACR has released an update to its official position statement on the use of…
Biosimilar Bill Prompts Formation of Nebraska Rheumatology Society
Last year, Nebraska rheumatologist Marcus Snow, MD, learned a biosimilar bill was up for debate in his state legislature, yet “I had no knowledge of it,” he says. Forming the Society The bill “was something that caught my eye, and I thought there should be a mechanism in place to allow us to disseminate information…
The Science Behind Biosimilars
Although six biosimilar agents have now been approved by the U.S. Food & Drug Administration for use in rheumatology, scientific, clinical, economic and prescribing questions about the use of biosimilars abound. In fact, at the 2017 ACR/ARHP Annual Meeting in San Diego, Joseph Huffstutter, MD, a rheumatologist in private practice in Chattanooga, Tenn., said that…
Etanercept Biosimilar Is Effective, Well-Tolerated for Rheumatoid Arthritis
NEW YORK (Reuters Health)—The biosimilar LBEC0101 is equivalent to etanercept (Enbrel) in treating patients with rheumatoid arthritis (RA) who respond inadequately to methotrexate, according to researchers from Korea and Japan. As Dr. Yeong-Wook Song tells Reuters Health by email, “LBEC0101 is comparable in efficacy, safety and immunogenicity profile to Enbrel.” The findings, he adds, could…
Health Plans Enact Coverage Policies for Remicade & Infliximab Biosimilars
Several major health plans have recently enacted policies regarding coverage status for Remicade (infliximab) and its biosimilars, Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda). Most of these plans are limiting coverage for the biosimilar products to very specific circumstances. Some have also begun denying claims for biosimilars and instructing patients to switch to Remicade. The plans implementing…
Pfizer’s Biosimilar of Roche’s Rituxan Succeeds in Study
(Reuters)—Pfizer Inc said on Wednesday its biosimilar of Roche’s Rituxan was as effective as the original drug in treating patients with a type of follicular lymphoma, meeting the main goal of a study. The success of Pfizer’s biosimilar comes as Rituxan’s U.S. patent is set to expire later this year. The drug had raked in…
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