Clinical - Page 2

Given that anti–tumor necrosis factor (anti-TNF) agents are able to suppress mucosal inflammation, some have posited that these drugs could play a role in mitigating immune-related enterocolitis.
Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA." 
At 6 months and 1 year, respectively, survival rates among the suboptimal responders who stayed on their index anti–tumor necrosis factor (anti-TNF) agent were 90.2% and 85.1%, respectively.
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.
Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.
In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.
The Center for Biosimilars® recaps the top stories for the week of December 9, 2019.
Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.
While biosimilars approved by regulators have been shown to have no clinically meaningful differences from their reference products, this week, during the San Antonio Breast Cancer Symposium, held in San Antonio, Texas, researchers will report reassuring data for biosimilar trastuzumab, Ogivri, showing that the combination of the biosimilar with pertuzumab is highly similar to the combination of the reference drug with pertuzumab.
During this week’s 61st meeting of the American Society of Hematology (ASH), researchers reported on eculizumab, a prospective biosimilar, and the long-acting ravulizumab.

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