Biosimilar trastuzumab made in tobacco plants | Regulatory Doctor
Canada-based PlantForm have altered tobacco plants to create a biosimilar version of Roche’s breast cancer drug Herceptin (trastuzumab).
The company licensed the technology from the University of Guelph in Ontario, Canada, where it was developed by Dr J Christopher Hall, the Canada Research Chair in Recombinant Antibody Technology.
The brand-name drug, Herceptin, is currently produced in animal cells, which is complicated and expensive. Tobacco plants, on the other hand, grow quickly and their biology is well-known by scientists. Humans and tobacco plants also have the same cell system. Since these plants just require water and sunlight to grow it is a much cheaper way to produce the drug.
This is not the first time plant technology has been used to create biosimilars. During 2011–2012 monoclonal antibody biosimilars, palivizumab and rituximab, were produced in non-transgenic green plants by biotechnology company iBio [1, 2].
An efficacy study in mice has shown that PlantForm’s biosimilar trastuzumab antibody drug is as effective as Herceptin in reducing the size and growth rate of breast cancer tumours.
The next step for the company is to carry out clinical trials in humans, which are expected to begin in 2014. PlantForm then expects to launch its biosimilar trastuzumab, in partnership with a pharmaceutical company, in world markets in 2016.
Herceptin has sales of C$6 billion annually and treatment with Herceptin can cost as much as C$100,000 per patient per year, according to PlantForm. The brand-name drug will lose patent protection in the EU in 2014 and in the US in 2017, causing PlantForm to focus its efforts first on Europe. PlantForm expects its plant-based production system to lower manufacturing costs by as much as 90%, making the biosimilar an affordable alternative.
The total market potential for all biosimilar trastuzumab products is estimated by PlantForm to be C$2 billion a year by 2016 and C$4–5 billion a year by 2019.
PlantForm’s technology platform is capable of producing a wide range of biopharmaceutical products, including monoclonal antibodies, protein drugs and vaccines. PlantForm is also developing biosimilar versions of two additional cancer drugs that have combined annual global sales of C$11.4 billion.