August 18th 2022
By Craig Burton
In response to another opinion piece, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and lower drug prices as a result.
August 17th 2022
By Skylar Jeremias
The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.
August 16th 2022
Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.
August 11th 2022
By Sarfaraz K. Niazi, PhD
Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.
August 8th 2022
While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.
August 4th 2022
By The Center for Biosimilars
In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.
July 25th 2022
Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.
July 24th 2022
On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.
July 21st 2022
In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.
July 12th 2022
A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.
