US FDA issues 17 observations for Biocon Biologics sites
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
The observations primarily relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications & computerized tools
This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.
The proposed transaction involves the sale of the global biosimilars portfolio of Viatris to Biocon Biologics
Abevmy follows the launch of the company’s two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product
BBL will gain Viatris’ global biosimilars business whose revenues are estimated to be USD 1 billion next year, along with its portfolio of in-licensed biosimilar assets
Branded and unbranded versions of the first-ever interchangeable biosimilar in the U.S. provide more affordable options for the millions of Americans living with diabetes
BRIDGE-1 Comprehensive care programme for Type 1 diabetes and to train 400 physicians and benefit over 1000 children
Subscribe To Our Newsletter & Stay Updated