John Gabrielson Discusses the Challenges of Launching Similis Bio

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, talked about the challenges associated with launching a business venture like Similis Bio and how Similis Bio's business model differs from other biosimilar developers and their spin-offs.

Transcript

Similis Bio is a relatively new company in the biosimilars game, being a biopharmaceutical business division of JSR Life Sciences. However, they are not the only new players—Novartis has announced spinning off Sandoz into a separate company and Merck has done the same with Organon. How is Similis Bio different from other biopharmaceutical companies and what are some of the challenges associated with launching a new company in this space?

Gabrielson: Yeah, Similis Bio actually differs quite a bit from the spin-offs you mentioned. One thing, Similis is focused exclusively on preclinical CMC [chemistry, manufacturing, and control] development of biosimilars. So, this includes things like analytical development, cell line and process development, and formulation development. From there, we find partners to take the products forward through clinical development and commercialization.

The other thing I wanted to mention, we aim to introduce new efficiencies into the biosimilar development paradigm, like multi-use data and purpose-built information packages. So, I think that also distinguishes us.

You also asked about challenges. Launching a new venture in the biosimilar space does have unique challenges. It's a rapidly growing sector of the industry and it's a highly competitive one. The market's crowded and we believe it's also, at this time at least, a very inefficient marketplace. And that's an area where I think we can really help.

We're reimagining what biosimilar development can look like in a global marketplace where the winning products will be both cost competitive, and have top tier quality.

Similis Bio’s business model functions by helping biopharmaceutical companies navigate the drug development process, improve efficiency, and reduce cost. How does Similis Bio work with other companies to achieve those goals and what does Similis Bio look for in a company partnership?

Gabrielson: Yeah, I appreciate the question on the business model and the partnership. So, first of all, our business model really seeks to do 2 things. We want to make biosimilar development faster and make it more cost effective.

We accelerate development by creating made to order assets ready to license eliminating, in some cases, up to 2 years of preclinical development and allowing companies to start nonclinical and clinical development immediately. We make biosimilar development more cost effective by making noncompetitive reference product information available to companies on a nonexclusive basis.

As it relates to our business model, we develop biosimilar products that are highly similar to the reference products and ready to enter clinical trials. Compared to novel biologics, biosimilars achieve most of their value during preclinical development before even 1 human is dosed. So, in this way, we're positioning Similis as a value creation engine for biosimilars.

I think a good partnership leverages the strengths and resources of each party. So, we look for companies with a long-term mindset, who value quality and with the resources to take the preclinical clinical biosimilars that we develop through clinical development and, eventually, marketing authorization. We need to have aligned values with our partners, and notably, this would include a mission to make high-quality biologics globally accessible.