27 October 2022 - - US-based JSR Life Sciences, LLC's Similis Bio recently launched biosimilar development business unit has signed its first development and license agreement with Brazil-based Blau Farmaceutica, the company said.

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.

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 100m. The companies are not disclosing additional financial terms.

These four biosimilars have an addressable market in the world of more than USD 42bn and, in Brazil, of close to USD 1bn, 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.

JSR said it 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 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 seven Latin American countries and the United States, and has a pharmaceutical industrial complex, consisting of five industrial plants, with technology, dedicated to the production of biological, oncological, antibiotics, injectable anesthetics and biotechnology.

A business unit of JSR Corp., 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.