The Center for Biosimilars Staff

May 08, 2018

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today.

May 03, 2018

While adalimumab and methotrexate are understood to have a synergistic effect, the MUSICA trial sought to evaluate the ideal dose of methotrexate needed in patients who receive combination therapy for rheumatoid arthritis.

May 02, 2018

Formycon and its licensee Bioeq today announced positive interim results for a phase 3 clinical trial of FYB201, a proposed ranibizumab biosimilar referencing Lucentis, which is an anti–vascular endothelial growth factor therapy approved to treat patients with neovascular age-related macular degeneration.

April 30, 2018

While systemic inflammation is a potential biological mechanism underlying both Parkinson disease (PD) and inflammatory bowel disease (IBD), clinical data on comorbid PD and IBD are few. In a new study published in JAMA Neurology, researchers report on a retrospective cohort study that assessed the incidence of PD among patients with IBD and sought to identify whether anti–tumor necrosis factor (anti-TNF) therapy for IBD alters the risk of PD.

April 28, 2018

While injectable drugs, including some innovator anti–tumor necrosis factor inhibitors and their biosimilars, have revolutionized the treatment of rheumatic diseases like rheumatoid arthritis (RA), hand disability can limit the ability of patients with RA to use syringes to administer medication. Prefilled, disposable auto-injectors may help to alleviate this issue and have demonstrated acceptability studies, but questions have remained about whether patients with reduced manual dexterity may still experience needle displacement when using these devices.

April 27, 2018

The American College of Rheumatology (ACR) told CMS in a letter this week that short-term, limited-duration insurance plans could reduce or restrict access to crucial care for people living with rheumatic diseases.

April 26, 2018

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.

April 23, 2018

Australia has been seeking to support the approval and uptake of biosimilar medicines as a way to alleviate pressure on its national health system.

April 20, 2018

In a panel during the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, rheumatologist Madelaine Feldman, MD; Wayne Winegarden, PhD, of the Pacific Research Institute; and rheumatologist Angus Worthing, MD, chair of the American College of Rheumatology’s Government Affairs Committee, discussed trends in healthcare payment models.

April 19, 2018

At the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17, Earl “Buddy” Carter, Republican Congressman for Georgia’s first legislative district, highlighted his work to control the price of drugs for patients.