Shots: 

• John spoke about the agreement between Similis Bio (a biosimilar partner and affiliate company of JSR) and Blau Farmaceutica to develop products and license IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders

• Under the collaboration, Similis Bio will provide full processes and associated IP for tech transfer to Blau making it to utilize the licensed IP for GMP manufacturing and clinical development to seek regulatory approval 

• The interview gives an understanding of Similis’ vision to promote biosimilars and advance more productive development programs, raising the standard of care 

Smriti: To begin with, please give our readers a brief overview of the development and licensing agreement between Similis Bio and Blau. 

John Gabrielson: Similis Bio signed its first development and license agreement with Blau Farmacêutica. The agreement is a multi-product and multi-year deal to develop products and license IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders. 

We launched Similis only seven months ago, so this is an important first step in our strategy to develop biosimilars with proven analytical similarity to reference products, ready to initiate non-clinical studies and clinical trials.  Moreover, several features of this deal will benefit both parties in the long term.  Through this deal, Blau and JSR have the incentive to make commercially successful biosimilars from project inception through commercialization and market access. 

Smriti: Give our readers details about the four biosimilar products to be developed and licensed by Blau. 

John Gabrielson: As we noted in our announcement, the parties are not disclosing the identities of the four products.  However, I can say that the products address a range of debilitating diseases, including cancer and blood disorders, and we intend to provide more cost-effective treatment options for patients suffering from these diseases. 

Smriti: Highlight the key contribution of Similis Bio and Blau individually towards the development of these biosimilars. 

John Gabrielson: Similis and Blau have complementary capabilities.  So we structured this deal to leverage the specific biosimilar development aspects where each party excels.  Similis will complete all of the pre-clinical CMC development, including the development of cell lines, manufacturing processes, analytical characterization, and demonstration of similarity to the reference product.  Blau is an established generics company serving the South American market with experience sponsoring clinical trials and commercializing pharmaceuticals.  Together we are confident that we will bring top-quality biosimilars to the Americas and the rest of the world through regional partnerships. 

Smriti: In addition to the launch in North and South America, are there any other geographical locations in your plans for the launch of these or other biosimilar products? 

John Gabrielson: Similis was established to transform the global biosimilar marketplace by making reference product information readily available and developing analytically validated biosimilars.  There is a robust global market for well-developed pre-clinical biosimilars, and we are looking for partners in the Americas, Europe, Asia Pacific, and Middle East/Africa. 

Smriti: Are you looking for any other collaborations in the near future to expand the development and commercialization of your biosimilar products? 

John Gabrielson: Right now, we are working to establish deals with several other partners.  Some of those deals will take a similar form to the Blau agreement, while others will be structured differently.  For Similis, it is more about the goals and values of our partners than the structure of the deal. A good partnership leverages the strengths and resources of each party.  So, we look for companies with a long-term mindset who value quality, with the resources to take the pre-clinical biosimilars we develop through clinical development and marketing authorization.  We must have aligned values with our partners, most notably a mission to make high-quality biologics globally accessible. 

Smriti: As Similis was launched mainly to target the biosimilar market, tell us some more about your achievements in developing biosimilar products across a wide range of therapeutic areas. 

John Gabrielson: The Similis leadership team has experience working on CMC development of biosimilars for over ten years, having helped companies register more than ten biosimilars in various regions of the world.  This experience led us to recognize the tremendous promise of biosimilars to meet an unfilled health need worldwide. It also caused us to realize how inefficient the biosimilar market is in its current form. With Similis, we hope to realize the promise of biosimilars by making the market more efficient.     

Smriti: Lastly, how has Similis Bio paved the way for biosimilars to enter the market by mitigating innate barriers? 

John Gabrielson: The biggest barrier to the wider adoption of biosimilars is price.  Although reducing the cost to develop and produce biosimilars is only one factor affecting the price consumers pay, it is a very important factor.  By focusing on reducing the cost of developing and manufacturing biosimilars, we think we can help remove the biggest barrier to biosimilar access.  If the entire industry diligently commits to lowering the cost of biosimilars, we can perhaps cut development costs in half and reach tenfold more patients with life-saving biologics.       

Source: Canva 

About the Author: 

John Gabrielson is the Senior Vice President, Biosimilars & Head of Business, leading the Similis Bio division of JSR Life Sciences. John is a seasoned executive, company builder, and strategist with over 15 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading CDMO, he is now focused on accelerating biosimilar adoption across the industry. Throughout his career, John’s primary scientific focus has been to improve analytical methods, for which he has delivered invited presentations, been issued one patent, and written numerous articles and book chapters 

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