John Gabrielson Explains Similis Bio, Blau Farmaceutica Codevelopment Deal, Predicts Future of Biosimilars

John Gabrielson, senior vice president at JSR Life Sciences, offers insight into the recent codevelopment deal Similis signed with Blau Farmaceutica and his projections for how biosimilars will evolve in the coming years.

Transcript

Similis Bio recently signed its first codevelopment partnership with Blau Farmaceutica for 4 biosimilar products. How does this partnership differ from the common commercialization and licensing deals that the global biosimilars industry has been seeing increases of in recent years?

Gabrielson: Yeah, so, we're really excited about this partnership with Blau. And several features of this deal, I think, will benefit both parties in the long term. So, most importantly, Blau and JSR both have the incentive to make commercially successful biosimilars from the very beginning of the project to the very end to commercialization and market access.

We structured the deal as a hybrid development and licensing agreement. Some of the assets are ready to licensed immediately, and others were just starting now. So, as we've seen over the past 6 months or so as we've talked with biosimilar companies, we've learned that there's a robust global market for both fully developed preclinical biosimilars and then many companies are looking for co-development agreements. So, we combine those 2 approaches in this in this deal.

How do you expect the biosimilars market to develop in the future, especially as the United States prepares for the introduction of several adalimumab and ustekinumab biosimilars over the next couple years?

Gabrielson: Yeah, so thanks for the question. We will first continue to see price competition in the US as more biosimilars enter the market. I think most people know that, and I hope the pricing pressure will translate into cost savings for patients. Ultimately, that's our goal, and I think that's everyone's goal.

Some of the other changes are less obvious, like potential regulatory relief on clinical and nonclinical requirements. The softening of clinical conditions will necessarily lead to increasing preclinical requirements. Notably, as clinical requirements become more streamlined, we expect the rigor of analytical CMC [chemistry, manufacturing, and control] development, which is something similar says routinely to increase substantially as regulators place more emphasis on state of the art methodologies to characterize the biosimilar product.

Ultimately, this will lead to reduced residual uncertainty. The higher that we can make the bar for demonstration of analytical similarity between the biosimilar and the reference product, the higher the likelihood that the product will be ultimately approved.