January 11th 2024
By Skylar Jeremias
As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.
January 10th 2024
The European Medicines Agency (EMA) has granted marketing authorization to the first ustekinumab biosimilar, STADA Arzneimittel and Alvotech’s Uzpruvo.
January 8th 2024
By The Center for Biosimilars Staff
Intro to Biosimilars is now in session! Test yourself on how well you know these biosimilar basics.
January 7th 2024
By Brooke McCormick
Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.
December 31st 2023
On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
December 30th 2023
The top 5 most-read regulatory stories of 2023 covered the FDA approvals for the first ustekinumab biosimilar and the first subcutaneous infliximab product, as well as other regulatory updates.
December 24th 2023
Brian Biehn and Corey Ford from Cencora suggest improvements to current regulatory frameworks to better promote biosimilars for US patients and ensure market sustainability.
December 20th 2023
At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
December 19th 2023
The FDA approved Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn), the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.
December 18th 2023
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.
