On April 6, 2021 PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz (Health Ministry of Brazil) reported a collaborative research and development agreement to develop a biosimilar pembrolizumab for the Brazilian market (Press release, PlantForm, APR 6, 2021, View Source [SID1234577647]).
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The original antibody drug, pembrolizumab, is widely used in immunotherapy to treat a variety of cancers including melanoma, lung cancer, head and neck cancer, and stomach cancer.
"This agreement advances PlantForm’s collaborations in Brazil to make affordable, effective cancer drugs available to millions of Brazilians," said Dr. Don Stewart, PlantForm’s President and CEO. "It also advances PlantForm’s global strategy for biosimilar drug development and manufacturing to increase affordability and access to a wide range of life-saving medications."
"Since 2015 when ANVISA approved the first biosimilar in Brazil it paved the way for more people to have access to advanced health treatments," said Germana Regazzi, PlantPraxis Director. "We want to make a difference in this market by transferring an innovative technology that will bring a low-cost biosimilar pembrolizumab to Brazil."
"Bio-Manguinhos, a pioneer institution in the development and production of vaccines, biopharmaceuticals and diagnostics and a protagonist in the production of biosimilars in Brazil, is now investing in plant-based technology. We strongly believe it can be an important option to bring high quality/low cost biopharmaceuticals and vaccines to the Brazilian Universal Health System (SUS). PlantForm holds one of the most promising technologies in the field, representing an ideal partner to pursue this goal," commented Sotiris Missailidis, Deputy Director of Technological Development of Bio-Manguinhos/Fiocruz.
The original drug (Keytruda by Merck) is a global market leader in oncology treatment and is on track to be the world’s best-selling drug by 2025 with annual projected sales of US $22.5 billion. It will lose exclusivity protection in the U.S., EU and Brazil in 2028.
PlantPraxis is a joint venture between PlantForm do Brasil (a wholly owned subsidiary of PlantForm Corporation) and Axis Biotec Brazil to develop and commercialize certain biosimilar and/or biobetter versions of key biologic drugs using the vivoXPRESS manufacturing platform for biopharmaceuticals. Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and biopharmaceuticals to meet public health needs.
With this partnership, the three-year research and development initiative will culminate in protocols for Phase 1 and Phase 3 clinical trials. Following successful completion of clinical trials and market entry in Brazil through Bio-Manguinhos/Fiocruz, PlantForm and PlantPraxis will take biosimilar pembrolizumab to world markets.