The Cost of Stakeholder Trust: A Barrier to Biosimilar Access

Just over ten years ago I was part of a collaborative research project that investigated how the complex interplay of patent regimes, pharmaceutical regulation, engagement by foreign donors and civil society, local production capacity, health systems and supply chain efficiency influenced appropriate and affordable access to medicines in India, South Africa and Uganda. More specifically, the project examined the production, distribution, supply and consumption of medicines through the lens of 8 tracer drugs that were (and still are) commonly used in various national health programmes, including HIV and TB, malaria, reproductive health, mental health, and diabetes.  The drugs were already off-patent and included amlodipine, ciprofloxacin, fluoxetine, lamivudine, metformin, oxytocin, rifampicin, and simvastatin. The project produced a number of publications in which various barriers to medicine access were identified, analysed and discussed (1 – 6). The reason for mentioning this very extensive study, which lasted for more than three years and involved several institutions, is because at no time during our investigation did we encounter patient- and prescriber resistance as a significant barrier to the use of these generic medicines. The same, unfortunately, cannot be said for the use of biosimilars.

I have recently started a new project with the aim of determining the reasons why manufacturers of human insulin have not responded to an expression of interest (EOI) issued by WHO in 2019 for assessment of applications of their products (soluble and intermediate-acting insulin) for prequalification (7). This is difficult to understand as there are no patents on the product and the request was limited to human insulin filled in vials; hence, patents on administration devices was not a barrier. This is unlike the case with rituximab and trastuzumab for which a similar procedure was initiated in July 2018 by WHO and which subsequently led to a trastuzumab biosimilar being prequalified in December 2019 and the first rituximab biosimilar, in May 2020. I have since found that an almost similar situation has manifested in our local market. Companies that originally registered human insulin biosimilars have decided not to market their products, because of economic reasons.   It is claimed that any successful commercialization of human insulin requires a comprehensive and continuous marketing and education effort, including the employment of diabetic educators and nurses. Another factor is that the cost of the originator products has decreased over time. Novo Nordisk, one of the three largest producers of insulin, has set their ceiling price for human insulin in vials at USD 3.00 in 76 least developed countries, as defined by the United Nations, as well as in several low and middle income countries, as from August 1, 2020 (8).

The problem with insulin reflects a much wider issue that affects all biosimilar products, which is the factoring into the final price, the often substantial cost of creating awareness among patients and prescribers that there are no differences in quality, safety and efficacy between originators and their biosimilars. Company-sponsored education programmes are also seen as part of marketing campaigns and, hence, not always ideal for creating trust among healthcare professionals. It would be far better if SAHPRA launches an education programme to build trust in biosimilars among patients and physicians. A good starting point would be to publish an information guide to physicians, similar to that of the EMA (9).  It should also take part in conferences and workshops for healthcare professionals to explain the stringent criteria applied to the registration of biosimilar medicines and to bring to the notice of these stakeholders the extensive global use-experience, gained over more than 20 years, which prove that biosimilars produce the same clinical outcomes as originators.     

Readers are encouraged to share their views in the comments section, especially on insulin biosimilars.

Bibliography

  1. K Ward, D Sanders, H Leng, AM Pollock.  Assessing equity in the geographical distribution of community pharmacies in South Africa in preparation for a national health insurance scheme. – Bulletin of the World Health Organization, 2014
  2. Leng HMJ, Sanders D, Pollock AP. Pro-generics policies and the backlog in medicines registration in South Africa: Implications for access to essential and affordable medicines. GaBI J 2015;4(2):58-63. DOI:10.5639/gabij.2015.0402.014
  3. Leng, H M J, Pollock, A M, & 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. SAMJ, 2016, 106(4), 350-353. https://dx.doi.org/10.7196/samj.2016.v106i4.10237
  4. Magadzire BP, Ward K, Leng HMJ, Sanders D. Inefficient procurement processes undermine access to medicines in the Western Cape Province of South Africa. S Afr Med J. 2017 Jun 30;107(7):581-584. doi: 10.7196/SAMJ.2017.v107i7.11356. PMID: 29025446.
  5. BP Magadzire, B Marchal, K Ward. Improving access to medicines through centralised dispensing in the public sector: a case study of the Chronic Dispensing Unit in the Western Cape Province, South Africa. BMC health services research, 2015, 15 (1), 1-8.
  6. Pharmacovigilance in India, Uganda and South Africa with reference to WHO’s minimum requirements. K Maigetter, AM Pollock, A Kadam, K Ward, MG Weiss

International journal of health policy and management, 2015, 4 (5), 295

  • 1st Invitation to Manufacturers of human insulin to Submit an Expression of Interest (EOI) for Product Evaluation to the WHO Prequalification Team – Biotherapeutic Products (BTPs)