Accelerating Biosimilar & Biobetter Drug Development

Accelerating Biosimilar & Biobetter
Drug Development
Version:
101716

File Name/Number:
20340

Year:
2016

A new era of biologic drugs has begun. Biosimilars and biobetters are approved follow-on versions of innovator biologics that provide opportunities for reducing the cost of treatment without compromising quality.

The development pathway of a biosimilar or a biobetter is different from that of novel biotherapeutics, requiring increased bioanalytical testing. Requirements for comparability, efficacy, and potency testing often demand a complex set of bioassays and/or cell-based assays for biosimilars and biobetters. Developers of these follow-on biologics have found this need for cell-based assays to be particularly challenging.

DiscoverX addresses this challenge with commercially available, ready-to-use cell-based assays for >30 biosimilar targets. These qualified fit-for-purpose, off-the-shelf assays save drug developers at least 6 months of assay development time, accelerating a path to regulatory submission. Initiate and complete comparability and method development with an easy-to-use assay protocol that generates rapid results in 24-48 hours, increasing overall assay reproducibility and ease of transfer, globally.