South Africa approves first non-originator biological

Biosimilares/Novedades | Posted 01/12/2017 post-comment0 Post your comment

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).

Stem Cell V13E24

The MCC, which is part of the Department of Health of the Republic of South Africa issued final guidelines for biosimilars, which follow the European Medicines Agency (EMA) guidelines, on 2 May 2012.

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy for cancer treatment.

In South Africa, filgrastim is recommended as an essential treatment for: ‘1. peripheral blood stem cell harvesting in autologous stem cell harvesting in haematological malignancies, and 2. chemotherapy-induced febrile neutropenia’ [1].

Teva’s product is a non-originator biological version of Amgen’s Neupogen (filgrastim), which had worldwide sales of US$1.4 billion in 2013 before the approval of the first filgrastim biosimilars [2].

The long-awaited approval marks South Africa’s first approval of a non-originator biological. However, some have criticized the country’s fast-track registration policy for creating a backlog and delaying access to many important medicines, including non-originator biologicals [3]. It has therefore been suggested that the MCC alter its strategy for the allocation of applications for evaluation from using a specific date of submission such as January 2012 (as it currently does) to selecting product classes or types for which there is a public need, irrespective of when the applications of such products were submitted.

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1. Cancer Alliance. Tomlinson C, Moyo H, Rizvi Z, Waterhouse C, Meyer S, Low M. Exploring patent barriers to cancer treatment access in South Africa: 24 medicine case studies. October 2017 [homepage on the Internet]. [cited 2017 Nov 30]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. South Africa’s expedited registration policy not speeding up access to biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Dec 1]. Available from:

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