Gianna Melillo

Study: Pharmacists Should Learn Nuances of Biosimilars

April 07, 2020

There are multiple distinctions in labeling indications between biosimilars and brand products, and pharmacists must become familiar with these to be of maximum service to patients and physicians, according to a review.

FDA Hopes to Accelerate Biosimilar Supplement Reviews

February 07, 2020

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The Most-Read Contributor Articles of 2019

December 26, 2019

In 2019, readers of The Center for Biosimilars® gravitated toward content reflecting the future of the market. Contributors from Amgen and Coherus BioSciences drew in readers with their assessments of new developments and practices to increase savings for patients, while other contributors took a look at how FDA guidelines will impact biosimilars.

The Most-Watched Interviews of 2019

December 25, 2019

This year, interviews with industry experts were the most popular among readers of The Center for Biosimilars. Touching on topics like market performance, cost, and government regulations, officials and professionals weighed in on the debates surrounding biosimilars and offered their opinions on how the industry can improve.