In Africa first manufactoring facility for biosimilars

South Africa

Africa will have its first biotech manufactoring facility for the production of biosimilars, thanks to Cipla BioTec, an Indian research, development, manufacturing and marketing organization focusing on biosimilar products, and Dube TradePort, a business entity of the KwaZulu-Natal Provincial Government in South Africa. The two parties will be building a fully integrated biopharmaceutical plant to make biopharmaceuticals within Dube TradePort Special Economic Zone in KwaZulu-Natal. They signed a Memorandum of Understanding for the commercial terms at a meeting in Goa, India, on the 14 October.

The state of the art facility is set to produce a range of affordable treatments for cancer and other autoimmune diseases for the African and global market. The construction of the new facility is scheduled to start in early 2017, with full operations expected to commence in the third quarter of 2018, where it is expected to generate at full capacity, some 300 jobs, with 180 of them being in the engineering and biological science fields, while a further 120 indirect jobs will be created.

The state of the art facility is set to produce a range of affordable treatments for cancer and other autoimmune diseases for the African and global market.

“As the KwaZulu-Natal Provincial Government – said Sihle Zikalala, KwaZulu-Natal Member of the Executive Council for Economic Development, Tourism and Environmental Affairs – we welcome this investment with open arms, as the technological level of this investment has the potential to impact on a number of economic and social facets of our society, well beyond the sizable investment in the new manufacturing facility and the estimated 180 permanent jobs that it will generate. The investment represents the introduction of an entirely new technology into the South African economy, which will have a wide reaching impact especially the elevation of the research and development done in our tertiary education institutions.

The nature of this investment is also socially important as it will provide lifesaving treatments for autoimmune diseases such as cancer, which are currently too prohibitive for the majority of South African citizens to afford. In our country, private medical aid schemes only fund health care services to about 16% of the population, where spending through those medical schemes is said to be at least six times higher than in Organisation for Economic Co-operation and Development (OECD) countries.”

Zikalala also noted, “The provision of affordable lifesaving medications to the majority of our economically active population will undoubtedly ease the burden on our society, ensuring that we have a healthier and highly productive population.”

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.

Biosimilars are approved biologics with comparable quality, safety and efficacy to a reference product. They are approved via stringent regulatory pathways (in highly regulated markets such as the EU, US, Japan, Canada and Australia) following loss of exclusivity of their originator reference products.

Biosimilars are approved biologics with comparable quality, safety and efficacy to a reference product.

The basis of approval for a biosimilar is demonstration of comparability (high similarity) to its respective reference biologic product. In other words, a biosimilar must be so similar to the originator biologic that statistically-speaking you can’t tell the two apart in terms of ability to treat the disease, safety profile and overall quality: the three things that matter the most to doctors and patients. They are different from generics in that they are not exact copies

The biosimilars that will be produced at the new facility is anticipated to be used by the state and private health care centers. In addition to local consumption, the life saving medication will also be exported to the to markets in Africa, US, European Union and Asia. These exports are expected to contribute towards South Africa’s economic growth.

Dube TradePort Corporation’s Chairperson, Bridgette Gasa, explained, “Cipla’s investment is further affirmation that we have created a world-class investment destination, which is conducive to doing business in South Africa. Dube TradePort Special Economic Zone (SEZ), together with the Province of KwaZulu-Natal, boasts reliable infrastructure, services and tax incentives to attract both Local and Foreign Direct Investments.”

“Cipla BioTec’s facility within Dube TradePort SEZ – Gasa added – will allow them to fulfill both the local need and that within the rest of the African market. The unique position of the new facility will enable seamless pharmaceutical export through the adjacent Dube Cargo Terminal as well as the multitude of connecting flights throughout the continent.”

 

by Michael Burgundy

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