The GBM Blog
Generic & Biosimilar Insights
Reflection paper on a tailored clinical approach in 4 biosimilar development
10 April 2025
This Reflection Paper will discuss the necessity of CES for demonstration of biosimilarity. In order to place those reflections into context, the Reflection Paper will first consider the current practice with respect to analytical comparability […]
IGBA releases first global Intellectual Property and Competition Report
10 April 2025
The International Generic and Biosimilar Medicines Association (IGBA) in line with its goals of promoting the widest possible access to safe, effective, and quality-assured medicines; and of promoting intellectual property regimes which foster innovation and […]
IGBA Support for a WHO Pandemic Agreement
10 April 2025
The generic and biosimilar medicines industry globally, represented by the International Generic and Biosimilar medicines Association (IGBA), supplies the overwhelming majority of prescription medicines to patients worldwide, and strongly supports ongoing multilateral efforts to achieve […]
In Support of Global Comparator for Biosimilars Waiving bridging studies concerning local versus global reference products
10 April 2025
I. Introduction The initial approval of a novel medicine in a country or region is usually supported by the same quality, non-clinical and pivotal clinical study datasets used for approval in other jurisdictions (notwithstanding additional […]
IGBA releases first global Intellectual Property and Competition Report
10 April 2025
The International Generic and Biosimilar Medicines Association (IGBA) in line with its goals of promoting the widest possible access to safe, effective, and quality-assured medicines; and of promoting intellectual property regimes which foster innovation and […]
Industry Updates
Global Biosimilars Week 2026: Realising the Global Value of Biosimilars
14 October 2026
From 19–24 October 2026, Global Biosimilars Week will bring together healthcare organisations, professionals, patient communities and pharmaceutical stakeholders from around the world. Now in its seventh year, the initiative was established by the International […]
Regulatory Framework for Generic Medicines in South Africa: Challenges and the Road Ahead
14 May 2025
South Africa’s pharmaceutical sector is essential to public healthcare, with generic medicines playing a crucial role in increasing drug accessibility and affordability. However, the regulatory landscape governing the approval of generic medicines is burdened with […]
Policy & Regulation
In Support of Global Comparator for Biosimilars Waiving bridging studies concerning local versus global reference products
17 March 2025
I. Introduction The initial approval of a novel medicine in a country or region is usually supported by the same quality, non-clinical and pivotal clinical study datasets used for approval in other jurisdictions (notwithstanding additional […]
IGBA position on Streamlined Development
17 March 2025
Position: Today’s regulatory science supports the development of biosimilars based on analytical (physicochemical and functional) data and a clinical pharmacokinetic study (which includes safety and immunogenicity data) alone. Clinical comparative efficacy studies using conventional efficacy […]
Healthcare Innovations
Regulatory Delays and Market Entry Barriers: A Bottleneck to Equitable Medicine Access in South Africa
3 July 2025
South Africa’s healthcare system faces a critical challenge that often goes unseen by the public but has a profound impact on access to essential medicines—regulatory delay. While the divide between public and private sectors sets […]
Addressing Medicine Accessibility in South Africa
21 May 2025
Medicine accessibility in South Africa remains a pressing public health concern, especially in a country burdened by a dual healthcare system and high rates of infectious and non-communicable diseases. While policy efforts have been made […]
The Gen Med blog
Bridging Innovation and Access: Rethinking the Role of Regulatory Systems in a Resilient Healthcare Future
21 November 2025
South Africa’s healthcare system stands at a pivotal moment. As it aims to strengthen access to affordable, quality medicines for all citizens, regulatory reform has become a cornerstone of national health discourse. Regulatory bodies such […]
The Power of Education: How Healthcare Providers Can Help Patients Understand the Safety and Efficacy of Generics and Biosimilars
21 November 2025
As South Africa expands the use of generic and biosimilar medicines within its healthcare system, the role of healthcare providers in patient education has never been more critical. Despite well-established regulatory standards and robust clinical […]
Navigating Regulatory Hurdles: How SAHPRA is Streamlining Approvals for Generics and Biosimilars
21 November 2025
Efficient regulatory processes are essential to ensuring that safe, effective, and affordable medicines reach patients without unnecessary delays. In South Africa, the South African Health Products Regulatory Authority (SAHPRA) plays a central role in the […]
The Role of Generic and Biosimilar Medicines in Managing Chronic Conditions in South Africa
21 November 2025
South Africa faces a growing burden of chronic diseases, including diabetes, hypertension, cancer, HIV/AIDS, and rheumatoid arthritis. As treatment regimens become more complex and long-term adherence becomes essential, access to safe, effective, and affordable medicines […]
Breaking Down the Basics: What are Biosimilars and How Do They Differ from Generics?
21 November 2025
Biosimilars and generics both play an important role in expanding access to affordable medicines, but they differ significantly in structure, manufacturing, and regulatory approval. Understanding these distinctions is essential for healthcare professionals, policymakers, and patients […]
The Road Ahead: Strategic Recommendations for Equitable Access to Medicines
10 October 2025
As South Africa navigates the complexities of medicine access, ranging from regulatory delays and affordability to supply chain disruptions and governance, there is growing consensus that sustainable improvement requires system-wide coordination. This final article in […]
Human Capital and Governance in Medicine Access
1 October 2025
Exploring workforce gaps, training, and institutional oversight A resilient health system is built not only on infrastructure and resources but critically on skilled human capital and sound governance. In South Africa, persistent workforce shortages, uneven […]
Strengthening Local Pharmaceutical Manufacturing and Supply Security
2 September 2025
Aligning Industrial Strategy with Health Access Needs South Africa’s dependence on imported pharmaceutical products poses significant challenges to medicine security, pricing stability, and health system resilience. The COVID-19 pandemic and recurring global supply chain disruptions […]
Policy Levers That Matter: Key Health System Interventions for Long-Term Access
20 August 2025
Access to medicines in South Africa is shaped by a complex intersection of regulatory frameworks, procurement mechanisms, pricing structures, supply chain logistics, and human resource capacity. While recent reforms have targeted specific challenges, such as […]
Control of Solid-State Characteristics of the Active Pharmaceutical Ingredients: Particle Size Distribution
26 September 2023
We are continuing our discussion on the importance of solid-state characteristics of the active pharmaceutical ingredient (API) on the quality and therapeutic efficacy of solid oral and inhaled dosage forms, and in this post the […]
Control of Solid-State Characteristics of the Active Pharmaceutical Ingredients: Polymorphism
21 August 2023
In the first post in this series on pharmaceutical specifications, I mentioned that characteristics or quality attributes of the active pharmaceutical ingredient (API) are generally divided into those that must always be controlled (appearance, identification, […]