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South Africa's first biosimilar oncology drug authorised for use

Cipla, South Africa's third-largest pharmaceutical manufacturer, in collaboration with Teva Pharmaceutical Industries Ltd, has announced the launch of the country's first biosimilar for the oncology and haematology markets.
Paul Miller, Cipla South Africa CEO
Filgrastim Teva, manufactured by Teva and distributed in South Africa by Cipla, paves the way for more affordable treatments to aid in the fight against dread diseases such as cancer, according to Paul Miller, CEO of Cipla South Africa.

“This landmark development for the South African pharmaceutical industry only happened after a thorough approval process. Not only does the approval of Filgrastim Teva hold major significance for the advancement of affordable supportive oncology treatments, but the learnings from this process will assist in faster approvals for more biosimilar medicines in future.”

A biosimilar is a “generic” version of a registered biologic medicine, meaning that it is a medicine produced from living cells using biotechnology (i.e. recombinant DNA technology, controlled gene expression or antibody technologies). Biologic technology has enabled the development of new treatments for many life-threatening and rare illnesses, such as cancer, diabetes, anaemia, rheumatoid arthritis and multiple sclerosis. However, original biologic medicines are often expensive. A biosimilar can be produced at a significantly lower cost, which reduces the price and increases the number of patients with access to the medicine.

A biosimilar is highly similar to the original biologic reference product in terms of quality, safety and efficacy. To prove this, various clinical studies including phase 3 safety and efficacy trials have to be conducted as part of the registration requirement.

“For every 1% that the price of these life-saving medicines drop, the number of patients that have access to them increases by 1%. Helping to increase competition in the market also means that patients could have access to newer and improved medications much sooner,” Miller says.

Filgrastim Teva is used as a supportive treatment to counter one of the major side-effects of chemotherapy. It often occurs that chemotherapy drugs disrupt the production of immune cells in the bone marrow of patients, leading to a condition known as neutropenia. If untreated, this can progress to neutropenic sepsis, which is a potentially life-threatening complication.

This new biosimilar works by stimulating bone marrow to produce new white blood cells. In doing so, it decreases the duration of neutropaenia experienced by patients after receiving chemotherapy.

“Introducing Filgrastim Teva to the South African market will enable us to reduce the cost of treatment for neutropenia significantly. Cancer patients are able to reduce their total oncology expense by using biosimilars such as Filgrastim Teva and more affordable generic chemotherapy treatment,” explains Miller.

“Filgrastim Teva will be the flagship product in Cipla’s existing Oncology portfolio of 28 molecules. A study published by medical journal Lancet, has predicted sub-Saharan Africa could see an increase of 85% in the number of cancer cases by 2030. This is a treatment that we feel very strongly about, and we see it as an industry-wide imperative to help to bring the cost of cancer treatment down.”

Avinoam Sapir, Senior Vice President and Head of Teva International Markets’ Israel, Turkey, Ukraine & South Africa cluster says that the company is pleased about Filgrastim Teva’s new availability to South African patients. “This is a testament to the strength of our research and design capabilities, and our commitment to producing high-quality, affordable biopharmaceutical products. Teva has nine years of international experience with Filgrastim in Europe and the US.”

“This is a proud moment for Cipla, and we hope that this is the first of many more oncology biosimilars to be introduced to the South African market. Together with Teva, we aim to truly make a difference in the lives of many more patients,” Miller concludes.


Sources:
1. Lalami, Y. & Klastersky, J. Impact of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) on cancer treatment outcomes: An overview about well-established and recently emerging clinical data. Clin. Rev. Oncol. Hematol. 120, 163-179 (2017).
2. Ford, A. & Marshall, E. Neutropenic sepsis: a potentially life-threatening complication of chemotherapy. Clin. Med. 14, 538-542 (2014).
3. Morhasan-Bello, I.O. et al. Challenges and opportunities in cancer control in Africa: a perspective from the African Organisation for Research and Training in Cancer. Lancet Oncol. 14, e142-e151 (2013).
4. Singh Sekhon, B. & Saluja, V. Biosimilars: an overview. Biosimilars. 1, 1-11 (2011).


Cipla's press office

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