Trastuzumab molecule

Trastuzumab molecule

11 December 2018
Prof Helen Rees
Chairperson: SAHPRA

Dear Professor Rees and officials at SAHPRA,

This letter could have been composed by ANY of the women in South Africa, diagnosed with HER2+ Breast Cancer who have been denied access to lifesaving treatment of Herceptin® by their private medical funder due to the cost of the medicine. Minister Motsoaledi announced at the National Cancer Campaign launch that this lifesaving medicine is now available in the public sector at the cost of R6 531.61 whilst in the private sector it is still priced at R19 015.09 for a 440mg vial and specifically made reference to the benefits of NHI. However, the Western Cape Health Department indicated that this treatment remains unaffordable and would be at the cost of other cancer patients.

Wonderful news to know that Tobeka Daki, a HER2+ breast cancer advocate, who died in 2016 being denied trastuzumab treatment by her Medical Aid in 2014, did not die in vain – her pleas for equitable access in the public sector have been heard.1 HOWEVER, we are still failing many women.

The registered South African patent 1998/11162, held by Roche expired on 7 December 2018. In the European Union, the blocking patents on trastuzumab have already expired in 2014 and several biosimilars have been approved by the European Medicine Agency (EMA) to stimulate competition in the market. Blocking patents will expire in 2019 in the US. 2

How does this impact the South African market?

There are currently at least three applications for registration of biosimilar trastuzumab products in South Africa pending at SAHPRA. In fact, some of these applications have been pending for more than one year. Our regulatory authority uses Level 4 Regulatory bodies such as EMA of the EU, FDA of the US, TGA of Australia and the Canadian Regulatory Authority as best practice for the approval of medicines. A number of regulatory bodies have already approved biosimilar registrations while in South Africa these applications remains pending at SAHPRA. Therefore, there is NO reason why these biosimilar applications should not be finalised in South Africa. The approval of biosimilars will stimulate competition in the market which would mean a more affordable price. That would mean more women would have access to this lifesaving medicine. It is as simple as that.

WHY is this delay by SAHPRA tolerated? For months now we have heard about labour strikes and restructuring of SAHPRA. All excuses that impact on the lives of patients that are denied access to treatment or are experiencing financial toxicity due to the exorbitant cost of the patented medicine. Whilst patents are not an approval criteria for SAHPRA, the expiry of patent 1998/11162, has cleared the way for biosimilar products. SAHPRA must end regulatory delays preventing their use. While Roche has licensed Mylan to market biosimilar trastuzumab in South Africa, the Cancer Alliance has repeatedly called on Roche not to seek to assert ongoing weak secondary patents granted without examination in South Africa, for which matching applications have been revoked or withdrawn in other jurisdictions, to challenge the introduction of other biosimilar products.3 We will continue to do this and monitor Roche’s response to the introduction of competitor products.

Prof Rees, we are asking you to make a meaningful difference for ALL women diagnosed with HER2+ Breast Cancer – STOP the delaying tactics and start focusing on the lives of patients that need essential medicines. You CAN! If the biosimilars had been approved earlier the price paid by government for the clone product HERCLON® could have been less and we would have been able to spend the savings on other essential cancer medication in the public sector.

Salomé Meyer
Email: | 079 483 3175

CANCER ALLIANCE EXCO: Nonku Boikhutso, Nersan Govender, Linda Greeff, Liz Gwyther, Peter Hers, Elize Joubert, Salomé Meyer, Zodwa Sithole

Minister Aaron Motsoaledi
Ms Precious Matsoso
Dr Anban Pillay
Ms Portia Nkambule


  1. Cancer Alliance, Fact Sheet Breast Cancer and HER2+ Breast Cancer with a look at Trastuzumab Access in South Africa, August 2018
  2. GaBi Online, Biosimilars of trastuzumab
  3. Cancer Alliance, Exploring patent Barriers to Cancer Treatment Access in South Africa: 24 Medicine Case Studies, October 2017

About the Cancer Alliance

The Cancer Alliance is a collective group of 30 cancer control non-profit organisations and cancer advocates brought together under a common mandate, to provide a platform of collaboration for cancer civil society to speak with one voice and be a powerful tool to affect change for all South African adults and children affected by cancer.

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