Similis Bio Makes Its First Licensing Deal for 4 Biosimilars in Latin America

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Similis Bio signed a licensing and codevelopment agreement with Blau Farmacêutica, allowing the latter to have exclusive development and marketing rights to 4 biosimilar assets in Latin America.

After JSR Life Sciences launched its business unit focused on biosimilars (Similis Bio), it announced the signing of its first codevelopment and license agreement for 4 biosimilar assets with Blau Farmacêutica, a São Paulo, Brazil–based company.

The companies said the biosimilars target indications in oncology, inflammation, and blood disorders but did not disclose what molecules they will reference. However, the biosimilars will have an addressable global market of over $42 billion, $1 billion of which is Brazil’s market. The transition will take several years.

“We launched Similis Bio as we saw the need to mitigate risk and accelerate timelines for biosimilar developers…. 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,” said John Gabrielson, senior vice president of JSR Life Sciences and head of Similis Bio, in a statement from the companies.

Under the agreement, Similis Bio will provide Blau Farmacêutica with full processes and licensing, including cell lines, analytical data and methodologies, and upstream and downstream processes. After the tranfer is complete, Blau Farmacêutica will be responsible for the domestic development and seeking regulatory approval in Latin American markets.

According to the companies, the launch of the drugs is a big milestone for Blau Farmacêutica and Brazil, which has a local producer for developing and producing active pharmaceutical ingredients (APIs) and biosimilar medicines in line with the Brazilian policies regarding independent production of APIs.

“This initiative will give the world population greater access to advanced medicines, raising the standard of care…. 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,” said Roberto Morais, executive director in charge of mergers and acquisitions and strategic alliances at Blau Farmacêutica.

As of July 2022, Brazil has 46 approved biosimilars and 7 more under review with ANVISA (The Brazilian Health Regulatory Agency), Brazil’s regulatory agency. In 2021, Celltrion Healthcare announced that it will enter the Brazilian biosimilar market, and in April 2022, the company won a 3-year tender contract for its infliximab biosimilar (Remsima). Additionally, Bio-Thera Solutions announced that it would bring a bevacizumab candidate to Brazil in December 2020. Samsung Bioepis expressed interest in entering the breast cancer and gastrointestinal markets in Brazil in August 2020 and it launched a biosimilar referencing Enbrel (etanercept) in September 2019.

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