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July 18, 2018
Article
At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.
July 17, 2018
Article
Under the agreement, AbbVie will grant Mylan a nonexclusive license to sell its drug in the United States and in other markets outside of Europe. The US license term for the biosimilar will start on July 31, 2023, and Mylan will pay royalties on its sales to AbbVie.
July 17, 2018
Article
In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.
July 16, 2018
Article
Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.
July 16, 2018
Article
In India, Razumab, manufactured by Intas Pharmaceuticals, was approved as a similar biologic to ranibizumab in 2015; the retrospective study RE-ENACT collected data and analyzed the effectiveness of this biosimilar product in the real-world setting in patients with age-related macular degeneration, diabetic macular edema, and retinal vein occlusion (RVO).
June 22, 2018
Article
Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologic drugs, including anti–tumor necrosis factor (TNF) agents, are often prescribed in cases in which patients fail to respond adequately to methotrexate.
June 21, 2018
Article
During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers presented on the roles of both existing and investigational anti-CD20 drugs in treating neurological diseases.
June 20, 2018
Article
Senator Orrin Hatch, R-Utah, has filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act, which was advanced to the Senate by the Judiciary Committee on June 14, 2018.
June 19, 2018
Article
A new study, published in Alimentary Pharmacology and Therapeutics, sought to test antigenic comparability between the reference infliximab and the biosimilar.
June 18, 2018
Article
Korean drug maker Celltrion has announced that it has resubmitted its Biologics License Application for CT-P6, a trastuzumab molecule referencing Herceptin. Separately, Celltrion announced new data for its proposed subcutaneous formulation of its flagship biosimilar, CT-P13, an infliximab biosimilar referencing Remicade, in patients with rheumatoid arthritis.