The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India. The agency listed 10 observations made during the agency’s inspection conducted during May and June of 2017.
The FDA’s Office of Surveillance has released its findings from an inspection of Biocon’s troubled manufacturing facility in Bangalore, India.
The FDA inspectors listed 10 observations made during the agency’s inspection conducted during May and June of 2017:
The extensive, 8-page report comes on heels of similarly critical assessment from the French National Agency for Medicines and Health Products Safety (ANSM), which noted 35 problems at the facility, 11 of which were deemed major deficiencies. The ANSM recommended to the European Medicines Agency that no batch of any of the 3 biosimilars addressed in its findings be supplied to the European marketplace, and that the marketing authorizations for the products be revoked until ANSM can verify that all of its recommendations have been implemented.
Biocon’s trastuzumab biosimilar, MYL-1401O, which the company developed in collaboration with Mylan, is among the drugs identified in ANSM’s report as being affected by the deficiencies. The FDA’s Oncologic Drugs Advisory Committee voted unanimously to recommend approval of MYL-1401O in its July 13, 2017 meeting, during which no mention of the facility’s issues was made. With regulatory action for MYL-1401O expected in September, the inspection report raises the question of whether approval of the drug could be delayed until Biocon takes corrective action in its facility.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On 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.
Coherus Biosciences Cites Biosimilars as Main Drivers of 2023 Revenue Growth
March 14th 2024In its earnings report for the fourth quarter and full year of 2023, Coherus Biosciences detailed its rising revenue growth, which it partly attributed to increased sales for its pegfilgrastim and ranibizumab biosimilars.
Filgrastim Biosimilars in Europe: 15 Years of Real-World Evidence for Zarxio
March 13th 2024A review looking back at the last 15 years of experience with the first filgrastim biosimilar (Zarxio) provides a detailed overview on how filgrastim biosimilars came to be and the evidence behind why oncologists have come to accept them as standard practice.