Canadian biopharmaceutical innovator PlantForm Corporation and Bio-Manguinhos / Fiocruz (Health Ministry of Brazil) have signed a collaborative research and development agreement to develop a biosimilar pembrolizumab and up to five future products for the Brazilian and other world markets.

Pembrolizumab is widely used alone or in combination with other drugs to treat a variety of cancers including certain types of breast cancer, skin cancer (including melanoma), non-small cell lung cancer and more than a dozen other types.

The collaboration expands upon an agreement signed in early 2021 to enable scientific and technical cooperation aimed at bringing low-cost pembrolizumab to Brazil and to develop future products to meet the demand for more affordable drugs for the Brazilian healthcare system.

“We’re very pleased to continue working with our Brazilian colleagues to advance our strategy for making effective, affordable cancer drugs available to millions of Brazilians. This updated agreement is a clear sign of their faith in our low-cost, plant-based vivoXPRESS® manufacturing platform,” said Dr. Don Stewart, PlantForm’s President and CEO. “It will also allow Bio-Manguinhos to develop up to five future drugs using the platform.”

The brand name version of pembrolizumab — Keytruda® by Merck — is on track to be the world’s best-selling drug with annual sales expected to top $35 billion by 2028, when it will lose key patent protection in Brazil.

Bio-Manguinhos is a Brazilian government organization responsible for technology development and production of vaccines, reagents and biopharmaceuticals to meet the country’s public health needs. The collaboration with PlantForm will culminate with Phase 1 and Phase 3 clinical trials of biosimilar pembrolizumab. Following successful completion of clinical trials and entry into the Brazilian market through Bio-Manguinhos/Fiocruz, PlantForm will take biosimilar pembrolizumab to world markets.

Stewart said the pembrolizumab research program has been making excellent progress and the development pathway puts the PlantForm-BioManguinhos product in a solid position to be one of the first biosimilar pembrolizumab on the market in 2028.

“This project further validates the versatility and capabilities of our plant-based system for developing a variety of protein drugs and vaccines for tackling major diseases that afflict millions of people every year,” he said. “Our vivoXPRESS manufacturing platform is made-in-Canada innovation with the potential to make these important biologic drugs more accessible and affordable worldwide.”