From Knowledge to Practice: Biosimilar Training Strengthens Regional Capacity
July 2025, Johannesburg
Equipped with newly gained knowledge and greater confidence in assessing biosimilars, 28 regulatory assessors from eleven Southern African countries returned home from Johannesburg.
The first regional biosimilar training under the GHPP PharmTrain2 project was held from 14–18 July 2025 – organised in close collaboration with our long-standing partner, the Southern African Development Community – Medicines Regulatory Harmonisation (SADC-MRH) initiative. The workshop marked an important milestone for regulatory cooperation in the region.
Training content from the region – for the region
Biosimilars are more affordable alternatives to costly biological products, enabling broader access for patients to treatments for conditions such as cancer, diabetes, and autoimmune diseases. Their evaluation, however, requires specific regulatory expertise – particularly in assessing comparability with the reference product (see GHPP Report: High Interest in the PharmTrain2 Fellowship: A Tailor-made Contribution to the Drug Safety of Biosimilars in Africa). This was exactly the focus of the training.
Over two years, the modules were jointly developed by the fellows of the Biosimilar Fellowship, four experts from BfArM, and the PharmTrain2 team – practical, interactive, and based on a Train-the-Trainer approach. In Johannesburg, they were used for the first time outside the Fellowship group.
Five fellows from the partner authorities in Ghana (FDA Ghana), South Africa (SAHPRA), and Zimbabwe (MCAZ) took on the role of trainers. They led nine thematically focused modules on the quality assessment of biosimilars – covering manufacturing processes, analytical characterisation, and the concept of biosimilarity. The sessions were delivered in an engaging, well-structured manner, with a strong link to real-world regulatory practice.
Participants from eleven SADC member states brought varying levels of experience. Working in small groups, they assessed real dossiers provided by our project partner AUDA-NEPAD. Guiding questions supported their structured analysis, and the results were discussed in plenary. This hands-on approach not only reinforced learning but also fostered exchange beyond existing networks. Ghana’s inclusion in the trainer team – since not being part of the SADC-MRH collaboration – sent a strong signal, highlighting its role in strengthening inter-regional harmonization and networks.
Clear success – measurable impact
The results speak for themselves: every participant improved in the pre-post comparison. Self-assessed confidence in evaluation skills also rose significantly.
The training was practical, well-structured, and technically enriching.
Everything I learnt in this training was quite valuable. I feel confident to go actively work on my biological product dossiers without spending too much time, considering that I now know what I look for as a regulator.
These were just two of the many positive comments from the anonymous feedback forms.
The trainer team was commended for their expertise and engaging, interactive delivery.
A strong beginning
The Johannesburg workshop was more than a training course – it marked the beginning of a continental knowledge-sharing journey on biosimilars. The positive feedback, measurable learning successes, and strong commitment from all involved show that working together builds lasting capacity. Initiatives like this not only strengthen regulatory expertise but also pave the way for better access to safe and affordable treatments across Africa.