South Africa’s expedited registration policy not speeding up access to biosimilars

Generics/Research | Posted 16/09/2016 post-comment0 Post your comment

Since South Africa’s National Department of Health (DoH) implemented a fast-track registration policy in 2003 the large number of generics applications has led to a backlog in approvals [1]. This has led to concern that this backlog is having a detrimental effect on patient access to critical pharmaceutical medicines and in particular biosimilars [2].

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One important medicine for South Africa with its high incidence of tuberculosis [3] is linezolid, which is currently used for treating drug-resistant tuberculosis. The Medicines Control Council (MCC) received a fast-track application for the registration of a generic linezolid product in May 2013. However, 16 months after submission a final decision on the registration of the product was still outstanding. It was only after considerable pressure from concerned organizations [4] that the product was eventually registered in November 2014, 18 months after the application was submitted to the MCC. One of the primary reasons for the delay was most likely the fact that the fast-track review system is overloaded with generics applications.

Biosimilars are affordable biopharmaceutical medicines that are highly similar, but not necessarily identical, to their corresponding originators and, like their originator counterparts, are derived from recombinant DNA technology. Examples of first-generation biopharmaceuticals include insulin, erythropoietin, filgrastim and human growth hormone. Other more complex biopharmaceuticals include trastuzumab (Herceptin) and infliximab (Revellex). Although all first generation biopharmaceuticals have already been off patent for several years in South Africa, biosimilars of these medicines are still unavailable to the public. This is unlike the situation in many countries and regions, such as Canada, Australia, the US and the European Union with whose regulatory authorities the MCC is aligned.

In fact, the European Medicines Agency already registered several biosimilars of first-generation biopharmaceuticals before 2010 [5]. Since the MCC has decided to evaluate medicines submitted as of 2012 only, with those submitted prior to that date considered as being part of the backlog and, hence, not eligible for evaluation using the current registration pathways, it is very likely that some of the registration applications for biosimilars that have been registered in Europe are trapped in the backlog [6, 7]. South Africans are, thus, continuing to pay high prices for off-patent biopharmaceutical medicines simply because these products do not have competition from biosimilars.

The MCC should, therefore, conduct a search among the applications in the backlog to determine if it contains biosimilar applications that have already been registered in countries with whose regulatory authorities the MCC is aligned. The MCC should also consider changing their first-in-first-out system of review in favour of one based on public health importance.

The Department of Health (DoH) has recently recognized the shortcoming of the expedited registration process and the committee within the Essential Drugs Programme that considers and approves applications for fast-track review has since October 2015 requested from the MCC a list of registered generics of a medicine for which fast-track review has been applied. However, to stop the bottle neck that has developed in the fast-track pathway due to generics, it is important that the policy be amended to cap the number of generics of a medicine are allowed to be fast-tracked.

Based on the authors’ research [2] they propose that the number should be limited to at most seven generics per medicine [7, 8]. Clone applications or auto generics, i.e. generics applications from the originator companies or their subsidiaries, should be excluded since they can submit and have their applications approved before the patent on their originator product has expired. This will give them an unfair advantage over generics since they can enter the market with their clones before generics.

Furthermore, the authors found a strong relationship to exist between the date of registration (and, hence, market entry) and market share of a product and almost no relationship between product price and market share [7, 8].

Conflict of interest
The author of the research paper [3] did not provide any conflict of interest statement.

Abstracted by Henry MJ Leng, PhD, from School of Public Health, University of the Western Cape, South Africa.

Editor’s comment
Readers interested to learn more about the regulatory requirements of biosimilars in South Africa are invited to visit to view the following manuscript published in GaBI Journal:

Regulatory requirements for the development and registration of biosimilars in South Africa

GaBI Journal is now indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here

Related article
South Africa’s expedited registration policy for rapid access to critical medicines under threat by generics

1. Republic of South Africa. Health Department. Medicines Control Council. General information guideline. 2008 [homepage on the Internet]. [cited 2016 Sep 16]. Available from:
2. Leng HM, Pollock AM, Sanders D. The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa. S Afr Med J. 2016;106(4):43-6.
3. Coovadia H, Jewkes R, Barron P, Sanders D, McIntyre D. The health and health system of South Africa: historical roots of current public health challenges. Lancet. 2009;374(9692):817-34.
4. Médecins Sans Frontières. DR-TB patients, activists demand registering generic linezolid [homepage on the Internet]. [cited 2016 Sep 16]. Available from:
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: 
6. Medicines Control Council. Summary of the Industry Task Group meeting held at 09:00 on 17 March 2015 at the Civitas Building [homepage on the Internet]. [cited 2016 Sep 16]. Available from:
7. Leng HM, Pollock AM, Sanders D. The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa. S Afr Med J. 2016;106(4):43-6.
8. Leng HMJ, Sanders D, Pollock AM. Pro-generics policies and the backlog in medicines registration in South Africa: Implications for access to essential and affordable medicines. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):58-63. doi:10.5639/gabij.2015.0402.014

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