An important aspect when comparing a biosimilar to its reference product is to determine if it has antibody-dependent cellular cytotoxicity (ADCC). This can be a complicated process that requires tools for accurately determine ADCC.
An aspect of biosimilar development that is unique to the US is the determination of interchangeability. This means that patients that switch between the reference and the biosimilar should not experience reduced efficacy or safety because of the switch. In order to be compliant, a study involving at least three switches between biosimilar and the US approved reference product must be undertaken. Furthermore, there are guidelines for adequate postmarketing safety monitoring of interchangeable products.
Although there may be some physiochemical differences between a biosimilar and its reference product, there should not be bioanalytical differences. If there are such differences, additional studies should be conducted to determine if they are clinically meaningful.
We are still only in the infancy of biosimilar drug development. As time goes by and more biosimilars are approved, the guidelines set by the regulatory agencies are expected to mature and the requirements for biosimilar development will become clearer. This will likely result in more development and a bright future for biosimilars.
The iLite ADCC product portfolio is based on a reporter gene system and offers a convenient and powerful way of measuring the efficacy of antibodies to elicit ADCC in vitro.
It possesses all the hallmarks of optimal bioassays - excellent linearity, large dynamic window, specificity, repeatability, precision and accuracy - and introduces unique engineered homologues Target (+) and (-) Cells for a more complete picture of the intracellular events.
Find out more about why the iLite® ADCC Bioassay system are greater than the sum of its parts.