News

Newly published research reports on an analytical characterization of Samsung Bioepis’ biosimilar adalimumab, SB5, in comparison with the reference, Humira, using 3 different guidelines, showed that the 2 products are largely similar, and any of the minor differences are not clinically meaningful.
A newly published study discussed the potential for the anti–vascular endothelial growth factor agent bevacizumab (Avastin) and its cost-saving biosimilars to be used as second-line therapy for the treatment of patients with advanced hepatocellular carcinoma (HCC) who progressed while receiving standard therapy.
The Center for Biosimilars® recaps the top news for the week of February 18, 2019.
 
More payers began to significantly adjust their reimbursement strategies for biosimilars last year, according to pharmacy benefit manager (PBM) Magellan Rx Management.
In an interview with The Center for Biosimilars®, Mona Chitre, PharmD, CGP, chief pharmacy officer and vice president of clinical operations and health innovation at Excellus Blue Cross Blue Shield, said increased spending on specialty pharmacy products is a primary reason for health plans’ growing interest in developing strategies to address biosimilars.
Despite the fact that the investigation confirmed many of the allegations against Janssen, the bureau concluded that, "at this time, there is insufficient evidence" that Janssen's conduct prevented competition.
The World Health Organization has long recognized the need for a global harmonization of standards for biologics worldwide. In response, the United Kingdom's National Institute for Biological Standards and Control has developed the first international standard for infliximab.
Corticosteroids are often given as therapy for neurosarcoidosis, but there remains a need for more effective treatment, and infliximab is increasingly used in this context.
AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.
Pfizer received authorization from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.
 

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