Clinical

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.
The Center for Biosimilars® recaps the top news for the week of February 11, 2019.
Evidence to support treating inflammatory bowel disease (IBD), a category that includes Crohn disease and ulcerative colitis, with biosimilar infliximab continues to develop, and several new studies highlight the safety and efficacy of long-term treatment with CT-P13 (Inflectra, Remsima).
While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).
A recent study looked at the long-term stability of CT-P6, a trastuzumab biosimilar referencing Herceptin, to see if it had the same stability as the reference product.
 
Drug maker Gedeon Richter’s RGB-02 is undergoing development as a proposed biosimilar to the reference pegfilgrastim, Neulasta, and researchers recently reported on the results of a phase 3 clinical study of the drug versus its reference in patients with breast cancer who were receiving chemotherapy.
 
A recent study examining Medicare Part D reimbursement policies for off-label uses, using dermatology as a focus, found that health coverage decisions have significant shortcomings that could hamper patient access to evidence-based treatments.
GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.
The Center for Biosimilars® recaps the top news for the week of February 4, 2019.

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