Cipla To Set Up South Africa’s First Biopharma Facility

Indian drug maker Cipla, which made history in the African pharmaceutical market by breaking the HIV drug monopoly of world drug giants with its less than a Dollar-a-day generic supply in 2001, is all set to create another history by setting up the first bio-similar facility in South Africa, offering the poor patients there the cheapest cancer drugs.

Cipla said on Friday (July 8) that its proposed biotech subsidiary in South Africa will invest just over Rand 1.3 billion to set up the country’s first biotech manufacturing facility, for the production of biosimilars. Cipla, which owns Cipla Medpro, South Africa’s third largest drug maker, as well as Cipla BioTec, a biotechnology company focused on affordable biopharmaceuticals, will be able to transform the biosimilar market in the low income region with the local manufacturing.

“Biosimilars are important to enable access to advanced cancer and autoimmune treatments. These treatments are only used by about 8 per cent of patients who should be treated worldwide mainly due to the high costs of these drugs,” said Steven Lehrer, director of Cipla BioTec, in Friday statement.

“Cipla BioTec aspires to transform the biosimilars market worldwide, by significantly increasing access with its strategy of one global product standard at affordable pricing. Cipla BioTec’s unique manufacturing strategy is leveraged from its in house proprietary manufacturing software and single use technology,” he added.

Biosimilars are the equivalent of generic drugs in the biopharmaceuticals space. These comparatively safe and effective drugs are starting to be introduced worldwide with original biomolecules developed and patented by large research-based biotech giants. However, biosimilars remain too expensive for broad use outside of major western markets.

Cipla BioTec Pvt Ltd and South Africa’s Dube Tradeport Corporation will soon sign a Memorandum of Understanding for setting up the biosimilar plant, which will be located in the Department of Trade and Industries Special Economic Zone of Dube Tradeport in Durban. The plant will manufacture biosimilar drugs made from living organisms and used in the treatment of cancer and other diseases.

Construction of the plant is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018. According to Lehrer, the facility is expected to create upto 300 jobs (upto 180 high skilled jobs and 120 indirect jobs), primarily in the engineering and biological science fields.

“It marks the entrance of Cipla Ltd subsidiary, Cipla BioTec, into South Africa and will be run independently of the pharmaceutical’s existing manufacturing division, Cipla Medpro Manufacturing (CMM),” he said.

Recently, South Africa’s Health Minister Aaron Motsoaledi was quoted in the press that he is extremely concerned of the high costs of medical care, using cancer drugs as an example. “Just as the price of ARV’S were unaffordable then cancer drugs are devilishly unaffordable today,” he had told media adding that the same effort that was used to reduce the price of ARV’S to be used in the fight against other diseases.

According to the Motsoaledi, a breast cancer patient could pay up to R 500 000 for Herceptin for a year’s treatment. This makes it virtually unaffordable for both the private and public sector. In South Africa, people without access to private insurance have limited or no access to any biologic medicine due to the very high prices of the innovator molecules. Currently about 1-in-50 patients in Africa have access to biologic medication.

“We are striving to reduce this number to about 1-in-5 cancer patients through the production and supply of biosimilar medication at an affordable price. This embraces Cipla ethos of advancing healthcare for all,” the minister had informed.

The biosimilars produced at the Cipla facility will be for both state and private sectors and there is also the potential to export to markets in the US, European Union and Asia.

The capacity of this factory will have the potential for a vast majority of the products to be exported, thereby contributing significantly to the country’s economic growth and skill development, the company said.

Cipla’s investment in this facility will enable the creation of the first Bio-cluster on the African continent, said Subhanu Saxena, MD and Global CEO, Cipla Ltd.

“A world class 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,” Saxena said.
The biotech manufacturing facility will have the necessary design capacity and capabilities and will seek regulatory approvals to supply the local market and to export into the rest of Africa and Europe, he added.

Cipla BioTec is currently focussed on research and development, manufacturing and selling biosimilar products. The entity, which is a fully owned subsidiary of Cipla, has products in varied phases of development for treatment of cancer, auto-immune and other diseases. Through innovative technology and go-to-market solutions, Cipla BioTec also aims to create a transformational impact in the way these medicines are used globally.