The agreement assigns rights to four biosimilar programs across a broad range of indications to Blau for commercialization.
SUNNYVALE, California / Cotia, São Paulo 25, October, 2022 – JSR Life Sciences, LLC (JSR) and Blau Farmaceutica (Blau) (public company in Brazil B3 – BLAU3) today announced that Similis Bio (“Similis”), its recently launched business unit focused on biosimilar development, has signed its first development and license agreement with Blau Farmacêutica (“Blau”). The agreement, Blau’s most recent move into the biosimilars market, is a multi-product and multi-year deal to develop products and licenses IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders.
“We launched Similis Bio as we saw the need to mitigate risk and accelerate timelines for biosimilar developers,” said John Gabrielson, Senior Vice President at JSR Life Sciences and Head of Similis Bio. “We are thrilled to partner with Blau as they work to launch their biosimilar business initially in North and South America. We look forward to leveraging our expertise and experience to support programs that can provide additional treatment options for some of the most debilitating diseases patients face.”
Similis Bio will provide full processes and associated IP for tech transfer to Blau, including cell lines, analytical data and methodologies, and upstream/downstream processes. Blau will utilize the licensed IP for GMP manufacturing and clinical development and seek regulatory approval.
Blau has exclusive worldwide rights and intent to sell in America by itself and partner with local organizations in other regions. The agreement is structured with upfront payments and long-term royalties upon commercial approval for sale. Blau and Similis expect the total value of the contract to exceed USD 100 million. The Companies are not disclosing additional financial terms.
These four biosimilars have an addressable market in the world of more than USD 42 billion and, in Brazil, of close to USD 1 billion, according to IQVIA, ensuring a robust pipeline for the Company in the long term.
The launch of these drugs will be a milestone in the history of Blau and Brazil, which will have a local producer developing and producing APIs (Active Pharmaceutical Ingredients) and biosimilar medicines in line with the national policy of independence in the production of APIs.
“This initiative will give the world population greater access to advanced medicines, raising the standard of care. Blau continues to invest at a strong pace in the development of new APIs and new highly complex drugs, in addition to expanding its production capacity, geographic presence, and relevance in the health industry, ”said Roberto Morais, Executive Director in Charge of M&A and Strategic Alliances. “We are developing products for the next decade, and we will further add new products to our partnership. This strategic and disruptive agreement reinforces Blau's position in becoming a reference in the production of biosimilars in Latin America.”
JSR launched Similis Bio to mitigate the innate barriers to market entry for biosimilars and promote more productive development programs. Similis provides biosimilar drug developers with technology to accelerate development timelines and lower costs. By offering complete analytical and process development packages, Similis supplies companies with data to determine an appropriate biosimilar target and accelerate early program development. Data packages include reference product data, analytical procedures, process expertise, and CMC templates from a centralized model designed to give partners access to higher quality biosimilars at a lower cost than other development models.
Blau (BLAU3) is a leading Pharmaceutical Industry in Brazil in the institutional segment and a pioneer in biotechnology, with a portfolio of private brands of highly complex medicines focused on relevant segments in the industry, such as immunology, hematology, oncology, nephrology, specialties, antibiotics, acting in several therapeutic classes. Blau has a continental presence, currently in 7 Latin American countries and the United States, and has a state of the art pharmaceutical industrial complex, consisting of five industrial plants, with cutting-edge technology, dedicated to the production of biological, oncological, antibiotics, injectable anesthetics and biotechnology. For more information visit blau.com
A business unit of JSR Corporation, JSR Life Science LLC is changing human health as a strategic partner and pathfinder for the life sciences industry. Rooted in a history of materials innovation, JSR LS provides specialized products, materials, and services to biopharmaceutical companies and academic researchers. Together with its world-class affiliates, JSR LS offers best-in-class integrated services that de-risk molecule selection, accelerate biologic development timelines, increase clinical success rates, and develop novel in vitro diagnostics. JSR LS’s global network of affiliates includes Crown Bioscience, KBI Biopharma, Inc., Selexis SA, and MEDICAL & BIOLOGICAL LABORATORIES CO., LTD. The company operates R&D and applications labs, manufacturing facilities, and sales offices worldwide. For more information, visit JSRLifeSciences.com