Can We Accelerate Biosimilars Development Without Compromising Quality Or Safety?

By Tim Lowery

The biosimilar path to commercialization is inherently complex, which means products take longer to produce and cost more than generic versions of conventional drugs. I recently sat down with John Gabrielson from Similis Bio to discuss how our industry is working to navigate these issues. One recent proposal, published in Science, called for an end to the use of animal toxicity studies in biosimilar development. The author reasoned, in part, that because biosimilars are engineered from living cells, and animals do not have the same receptors that humans do, there are no true results in this process.