November 6th 2023
By Sarfaraz K. Niazi, PhD
The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
November 1st 2023
By Skylar Jeremias
The FDA approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference Stelara (ustekinumab). The biosimilar was also approved with an interchangeability designation.
October 30th 2023
By Ivo Abraham, PhD
In his comeback column, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores the world of biobetters and the complicated dynamics surrounding the FDA approval of Zymfentra, the first subcutaneous infliximab.
October 26th 2023
Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
October 25th 2023
As Celltrion releases new data on its subcutaneous infliximab product in gastroenterology conditions, Samsung Bioepis secures an interchangeability designation for Byooviz, making it the second ranibizumab biosimilar to be deemed interchangeable with the reference product.
October 23rd 2023
The FDA approved Celltrion’s Zymfentra (infliximab-dyyb), a novel drug that allows for subcutaneous administration of inflximab.
October 19th 2023
Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
October 16th 2023
Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.
October 14th 2023
Prince Edward Island became the eleventh jurisdiction in Canada to implement a biosimilar transition policy, in which patients who are currently taking select reference agents will transition to biosimilar versions.
October 10th 2023
Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
