Kelly Davio

May 28, 2019

Officials in British Columbia announced on Monday that patients currently taking reference biologics for rheumatological diseases and diabetes will be switched to biosimilar products within 6 months.

May 27, 2019

All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.

May 24, 2019

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

May 23, 2019

In an analysis presented at ISPOR 2019, a team of researchers sought to demonstrate the cost to incorporate biologic treatment for patients with inflammatory diseases by using biosimilar infliximab instead of its reference.

May 22, 2019

Treatment with the biosimilar, the investigators concluded, resulted in comparable, maintained quality of life improvements that were not impacted by a switch from the reference product.

May 22, 2019

During Digestive Disease Week 2019, held May 18-21 in San Diego, California, researchers presented the 1-year results of a phase 1 trial of subcutaneous CT-P13 versus the intravenous formulation of the biosimilar in patients with Crohn disease (CD).

May 21, 2019

The FDA today released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity. A previous draft guidance document on statistical approaches to evaluate analytical similarity was withdrawn in June 2018.

May 21, 2019

Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.

May 21, 2019

During the ISPOR 2019 annual meeting, teams of investigators presented data estimating just how much healthcare systems could save by adopting biosimilar adalimumab for all indications of its reference in adult patients. The results highlighted both the scale of potential savings and the variability among European nations.

May 20, 2019

Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.