October 5th 2023
By Skylar Jeremias
Pfizer’s Abrilada (adalimumab-afzb) became the second biosimilar referencing Humira (adalimumab) to receive an interchangeable designation. The new label is intended to expand patient access to biosimilars.
Tofidence, a tocilizumab biosimilar developed by Biogen, will be used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
October 3rd 2023
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
October 2nd 2023
September was graced with several regulatory updates from around the world, including some European and Japanese approvals, as well as the FDA’s 2-day workshop on the current science behind clinical efficacy testing for biosimilars and streamlining biosimilar development.
October 1st 2023
By Justina Petrullo
On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
September 30th 2023
By Camlyn Masuda, PharmD, BCACP, CDCES
Nuances in classification for insulin biosimilars can lead to frequent areas of confusion, according to 2 pharmacists.
September 27th 2023
With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.
September 25th 2023
Iceland-based Alvotech announced the approval of its ustekinumab biosimilar referencing Stelara in Japan for autoimmune conditions. The company also released an update on the US filing for its adalimumab biosimilar.
September 23rd 2023
By Gillian McGovern
The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.
September 21st 2023
The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.
