The Center for Biosimilars Staff

March 05, 2018

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

March 02, 2018

The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.

March 01, 2018

Richard G. Frank, PhD, a health economist at Harvard Medical School and the former deputy assistant secretary for planning and evaluation at HHS, has penned a new perspective paper in the New England Journal of Medicine in which he warns that, if biosimilars continue their trajectory, they could fail to deliver on their promise to provide cost savings to the US health system.

February 28, 2018

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

February 27, 2018

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

February 26, 2018

Over the past 2 years, commercially insured patients enrolled in plans that had value-based contracts for certain high-cost drugs had lower copays for their medications than did patients enrolled in plans without such contracts. That finding comes from “Delivering Results for Patients: The Value of Value-Based Contracts,” a new report from the Pharmaceutical Research and Manufacturers of America (PhRMA).

February 24, 2018

Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia.

February 22, 2018

Pharmacy benefit manager Express Scripts and Walgreens Boots Alliance, Inc, have announced that they will expand their group purchasing efforts to include specialty drugs, including biologics and biosimilars.

February 20, 2018

A white paper released this month by the Association for Accessible Medicines (AAM) says that brand-name drugs are behind high prescription drug costs, and that those costs aren’t only hurting patients’ financial wellbeing, but also endangering their health.

February 19, 2018

While corticosteroids are a common treatment for uveitis, effective corticosteroid-sparing therapies are necessary to maintain disease control without risking corticosteroid-related adverse events.