By: Tom Ransohoff (transohoffbptccom)
As expected, the Recovery for Biologics XV conference, which was held in Stowe, VT in early August, provided a great opportunity to learn about the latest research, case studies, and innovations in the bioseparations field. Among presentations on high-throughput techniques, continuous processing, facilities of the future, and advances in chromatography, there was also a lively session on biosimilars, which provided an ideal forum to share perspectives on this emerging part of our industry. While many uncertainties still exist around how and when biosimilars (or follow-on biologics) will provide significant competition to innovative products, it was clear from the discussion that most view this segment as an integral part of the biopharmaceutical industry’s future.
In reflecting on this topic after the meeting, I had an “Aha!” moment. Specifically, I began to realize that being truly successful in the biosimilars/follow-on biologics market will require highly sophisticated technical capabilities in the areas of process and analytical development. In fact, in my opinion, biosimilars companies will need to actually drive innovation and advance the state-of-the-art for process and analytical development.
There are several reasons for this requirement. First, biosimilars face the daunting task of proving that they are “highly similar” to the original reference product, as required by the Biologics Price Competition and Innovation Act (BPCIA). Second, this product and process understanding must essentially be in place prior to initiation of Phase 1 clinical trials, which is well in advance of when this would be required for a typical innovative biopharmaceutical product. Because a well-designed biosimilar product benefit from a lower risk of clinical failure, the initiation of Phase 1 trials will be followed quickly by registration-enabling trials thereby decreasing the time available for additional process development and characterization. Without the ability to proceed rapidly through clinical development using a robust commercial manufacturing process, much of the economic and speed advantage of developing a biosimilar product will be lost. Therefore, the need for truly innovative technologies to enable rapid process and analytical development, reliable scale-up, and cost-effective manufacturing is likely to be even greater for biosimilars companies than for innovators.
So, my “Aha!” moment boils down to this: in order to be successful, biosimilars companies are likely to need highly sophisticated process and analytical development capabilities, stimulating continued innovation in process and analytical development in a way that many of us may not be fully anticipating.