Kelly Davio


What Challenges Lie Ahead for Eventual Biosimilars of Advanced Therapy Medicinal Products?

February 25, 2019

Advanced therapy medicinal products (ATMPs), including gene therapies, cell therapies, and tissue engineering products, are providing groundbreaking approaches to treating rare diseases. However, the costs associated with these drugs are expected to pose challenges for affordability and the sustainability. A newly published paper looked ahead to the potential for—and challenges related to—biosimilars of ATMPs.

Bevacizumab and Cost-Saving Biosimilars Could Play a Role in Treating Advanced HCC

February 22, 2019

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.

For Health Plans Developing Approaches to Biosimilars, Engagement is Key

February 21, 2019

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.

Ahead of US Biosimilar Competition for Humira, FDA to Give AbbVie's Upadacitinib Priority Review

February 20, 2019

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.

Diverging from FDA, Health Canada Announces Suffix-Free Biologic and Biosimilar Naming Convention

February 18, 2019

Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix. The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands.