Samantha DiGrande

February 22, 2018

Gillian Woollett, DPhil, MA, senior vice president of Avalere, recently authored an article suggesting ways that the FDA can facilitate applications and approvals for interchangeable biosimilars.

February 21, 2018

An editorial recently published in The BMJ discusses addresses 1 of the most commonly misunderstood biosimilar concepts: extrapolation.

February 21, 2018

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

February 20, 2018

At the recent European Crohn's and Colitis Organisation’s 13th Congress in Vienna, Austria, several studies investigated the efficacy of infliximab biosimilars in treating Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA).

February 16, 2018

Scott Gottlieb, MD, Commissioner of the FDA, is calling for changes to biosimilar regulation to help facilitate biosimilar approval, market entry, and competition.

February 16, 2018

The TITRATE study is designed to investigate whether intensive management of RA leads to a greater number of remissions at 12 months, in addition to examining levels of disability, quality of life and acceptability, and cost-effectiveness.

February 15, 2018

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

February 13, 2018

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

February 12, 2018

South Dakota Senate Bill 75, a biosimilar substitution bill, is expected to be signed by South Dakota’s Governor, Dennis Daugaard-R.

February 09, 2018

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.