The first biosimilar for the treatment of breast and stomach cancers has been approved by the FDA, termed Ogivri.
2. Given the complexity and cost of development and manufacturing, are biosimilars more affordable therapeutic options?
In this ‘Ask the Experts’ feature, the experts discuss the complexity and cost of development and whether biosimilars are more affordable therapeutic options.
In this ‘Ask the Experts’ feature we will be discussing the use of biosimilars with a number of leading experts across the field. The series will explore the role of biosimilars, address the benefits and challenges of creating them and how they have gained momentum within the pharmaceutical industry.
Amgen and Simcere announce collaboration in the development and distribution of biosimilars in China
An exclusive agreement between Amgen and Simcere has been announced in the co-development and commercialization of four undisclosed oncology and inflammation biosimilars.
In this feature we ask the question: how can the biosimilars field be regulated and standardized?
We asked our experts: what have been the most exciting advances in developing biosimilars?
WHO have announced plans to include biosimilars for cancer treatments as part of their current prequalifying scheme, in the hope to make treatment more available in low income countries.
Rapid & comprehensive comparison of five versions of bevacizumab: Avastin versus its biosimilars (Protein Metrics)
Introduction As the pace of biosimilar development and commercialization increases, there is a clear need for…
This chapter presents an overview of the requirements of comparative and biosimilarity testing between the innovator reference products and biosimilars with respect to product quality attributes, nonclinical and clinical studies, and current regulatory guidelines for biosimilar product development.
Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars
In this chapter case studies are presented, which illustrate the assessment of critical assay performance characteristics for both PK and immunogenicity ADA assays to support comparability studies for biosimilar products.