Pembrolizumab is an antibody treatment for numerous types of cancer, including lung, stomach, and head and neck cancer. It targets the protein PD-1 which can stop the immune system from recognizing and destroying cancer cells.

First approved in the US in 2014, pembrolizumab has been sold under the brand name Keytruda by originator company Merck, who in 2020 announced the creation of a spin-off company to focus on the drug [1]. Patent protection on Keytruda will expire in Brazil, EU and the US in 2028.

On 6 April 2021, PlantForm announced a collaboration to develop a biosimilar version of pembrolizumab for sale in Brazil. PlantForm will work together with PlantPraxis and Bio-Manguinhos/Fiocruz (part of the Brazilian Ministry of Health) to develop the biosimilar.

Dr Don Stewart, CEO and President of PlantForm, said the agreement will advance the company’s existing collaborations in Brazil to increase access to cancer drugs in the country, adding: ‘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’.

PlantForm signed an agreement with Brazil-based company PharmaPraxis in 2014 to develop a biosimilar of bevacizumab (Avastin), which can be used to treat colon, lung and kidney cancer [2].

Under the new partnership, a three-year R & D initiative will lead to protocols for phase I and III clinical trials. Following successful completion of the trials and marketing in Brazil, PlantForm and PlantPraxis aim to sell the biosimilar elsewhere in the world.

Germana Regazzi, Director of PlantPraxis, said: ‘Since 2015 when ANVISA [the Brazilian Health Surveillance Agency] approved the first biosimilar in Brazil it paved the way for more people to have access to advanced health treatments. We want to make a difference in this market by transferring an innovative technology that will bring a low-cost biosimilar pembrolizumab to Brazil’.

Sotiris Missailidis, Deputy Director of Technological Development at Bio-Manguinhos/Fiocruz, added: ‘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’.

PlantForm’s proprietary technology (vivoXPRESS®) uses genetically modified tobacco plants to produce biological drugs, which they have used to develop a biosimilar version of the breast cancer drug trastuzumab (Herceptin) [3]. This technology is said to be faster, cheaper and easier than conventional methods of producing biologicals and is licensed from the University of Guleph in Canada, with whom PlantForm formed a partnership in 2016 [4].

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The biosimilars market in Latin America: a summary

Biosimilars of trastuzumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Merck to create spin off for women’s health and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Pharma-News/Merck-to-create-spin-off-for-women-s-health-and-biosimilars 
2. GaBI Online - Generics and Biosimilars Initiative. More biosimilars collaborations on the cards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Biosimilars/News/More-biosimilars-collaborations-on-the-cards 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab made in tobacco plants [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 April 23]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-trastuzumab-made-in-tobacco-plants 
4. GaBI Online - Generics and Biosimilars Initiative. Partnership between PlantForm and Guelph University for biosimilar trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 23]. Available from: www.gabionline.net/Pharma-News/Partnership-between-PlantForm-and-Guelph-University-for-biosimilar-trastuzumab

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