On 25 October 2022, JSR Life Sciences (and LLC (JSR)) have announced that their recently launched biosimilars development branch, Similis Bio, has signed a development and license agreement with Brazilian firm, Blau Farmacêutica.
The agreement is a multi-year deal to develop products and license IP for four biosimilar products targeting indications in oncology, inflammation and blood disorders. The products that these molecules will reference have not been disclosed. Blau and Similis noted that the addressable market for these biosimilars is US$42 billion globally and close to US$1 billion in Brazil, according to IQVIA.
Under the terms of the partnership, 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. In turn, Blau will utilize the licensed IP for good manufacturing practice (GMP) manufacturing and clinical development and be the entity to seek regulatory approval.
Blau will have exclusive rights to the products and intends to have them authorized in both North and South America. The agreement between Blau and Similis includes upfront payments and long-term royalties upon commercial approval for sale. The partners have divulged that they expect the total value of the contract to exceed US$100 million.
Roberto Morais, executive director in charge of mergers and acquisitions and strategic alliances at Blau Farmacêutica, said, ‘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’.
As of July 2022, it is reported that Brazil has approved 46 biosimilars, with more being considered for approval by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA). These are within the product classes of: 1) insulin; 2) monoclonal antibodies; 3) tumour necrosis factor (TNF) inhibitor; 4) human growth hormone; 5) anticoagulants and heparins; and 6) granulocyte colony stimulating-factor. The first biosimilar approved in Brazil was Remsima (CT-P13), an infliximab’s biosimilar, in April 2015 [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil
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