Global pharmaceuticals company Cipla announced in July that its proposed biotech subsidiary, Cipla BioTec South Africa (CBSA) will invest just over R1.3-billion into the country’s first biotech manufacturing facility, used for the production of biosimilars, and located in KwaZulu-Natal.
Cipla’s South African subsidiary Cipla Medpro – the third largest pharmaceuticals manufacturer in the country – and the biotechnology company will be focused on the manufacturing of affordable and accessible biopharmaceuticals.
A memorandum of understanding (MoU) between Cipla BioTec and Dube TradePort Corporation was signed on July 9 on the sidelines of the South Africa-India CEOs Forum when Indian Prime Minister Narendra Modi made his maiden visit to Pretoria. The MoU affirms Cipla BioTec’s and Dube TradePort Corporation’s commitment to the investment and outlines terms of reference for the project.
Following the July announcement, CBSA CEO Divian Govender commented that the factory, which will be located in the special economic zone of Dube TradePort in Durban, will manufacture biosimilar drugs made from living organisms and used in the treatment of cancer and other diseases. Biosimilars are designed to have the same characteristics as an original biological agent. Construction is scheduled to start in early 2017, with full operation expected to commence in the third quarter of 2018.
Cipla BioTec director Steven Lehrer explained that biosimilars enable access to advanced cancer and autoimmune treatments, which are only used by about 8% of patients that should be treated globally. The reason so few patients use these treatments is mainly because of the high costs of these drugs. “Biosimilars are as safe and effective as the original treatment and are starting to be introduced globally. However, biosimilars [currently] remain too expensive for broad use outside major western markets.”
Lehrer notes that CiplaBioTec aspires to transform the biosimilars market by significantly increasing access using its strategy of adhering to one global product standard, thus, ensuring affordable pricing. “CiplaBioTec’s unique manufacturing strategy is leveraged from its in-house proprietary manufacturing software and single-use technology.”
He states that, at full capacity, the facility is expected to create up to 300 jobs (up to 180 high-skilled jobs and 120 indirect jobs), primarily in the engineering and biological science fields. “It marks the entrance of Cipla BioTec into South Africa and will be run independently of Cipla’s broader South African subsidiary Cipla Medpro.”
Meanwhile, Health Minister Aaron Motsoaledi, who has on many previous occasions expressed his extreme concern about the high costs of medical care, citing cancer drugs as an example, commented: “Just as the price of ARVs were unaffordable then, cancer drugs are devilishly unaffordable today.” He called for the same effort that was used to reduce the price of ARVs to be used in the fight against other diseases.
He highlighted that a breast cancer patient could pay up to R500 000 for Herceptin for a year’s treatment. This makes it virtually unaffordable for both the private and public sector.
In light of this, Cipla Medpro CEO Paul Miller, in a July statement, explained that, in South Africa, people without access to private insurance had limited or no access to any biologic medicine because of the very high prices of the innovator molecules. “Currently, about one in 50 patients in Africa has access to biologic medication. We are striving to reduce this number to about one in five cancer patients through the production and supply of biosimilar medication at an affordable price. This embraces Cipla’s ethos of advancing healthcare for all.”
The biosimilars produced at the facility will be for both public and private sectors and there is also the potential to export to markets in the US, the European Union and Asia, Miller commented. “The capacity of this factory will mean it has potential for a vast majority of the products to be exported, thereby contributing significantly to the country’s economic growth and skills development.”
Cipla MD and global CEO Subhanu Saxena stated after the tradeport agreement that, “[Cipla’s] investment in this facility will enable the creation of the first biocluster on the African continent. A [high-quality] manufacturing base here in South Africa will allow opportunities for supply chain partners and related companies to get involved. This, in turn, will allow top-notch research efforts to stay in South Africa and attract research from international institutions as well.”
Possessing the necessary design capacity and capabilities, the biotech manufacturing facility will seek regulatory approvals to supply the local market and to export into the rest of Africa and Europe.