The GBM Blog
Generic & Biosimilar Insights
Supply Security Under Pressure: How Global Disruptions Are Reshaping Local Pharmaceutical Planning
24 February 2026
The pharmaceutical supply chain has entered a period of sustained volatility. Global disruptions, ranging from API shortages and geopolitical instability to shipping delays and currency fluctuations, are no longer episodic events but structural risks that […]
Regulatory Readiness in a High-Demand Environment: What 2026 Signals for Medicine Approvals in South Africa
17 February 2026
South Africa’s pharmaceutical regulatory environment continues to evolve in response to increasing demand for medicines, greater product complexity, and heightened expectations for regulatory efficiency. At the start of 2026, market authorisation holders, manufacturers, and local […]
From Understanding to Involvement: Closing the Trust Gap in Community Health Research
12 February 2026
In many communities across South Africa, the idea of participating in health research is often met with hesitation. While health research plays a crucial role in improving treatments and understanding public health needs, a significant […]
Why Conversations About Medicine Access Must Include Infrastructure, Not Just Innovation
10 December 2025
South Africa’s healthcare discourse is often dominated by innovation: new treatments, breakthrough therapies, digital platforms, and the evolving potential of biosimilars and generics. But beneath these advancements lies an issue that is far less glamorous, […]
The Economics of Equitable Access
10 December 2025
Medicine procurement and pricing policies are foundational to South Africa’s approach to equitable healthcare access. As the country contends with growing demands for chronic disease care, global cost pressures, and constrained public budgets, it becomes […]
Supply Chain Disruptions and Stockouts: Addressing a Persistent Threat to Medicine Access
17 July 2025
Consistent availability of medicines is one of the most fundamental requirements of a functioning healthcare system. In South Africa, ensuring continuous access to essential medicines remains a complex challenge, shaped by the interplay of procurement […]
Pricing Pressures and Affordability Challenges: Balancing Access and Sustainability in South Africa’s Medicine Market
10 July 2025
Medicine pricing in South Africa reflects a delicate balance between public health goals and pharmaceutical market sustainability. While pricing controls and transparency measures have been introduced to contain costs, challenges persist in ensuring that medicines […]
IGBA Welcomes the WHO Pandemic Agreement and Calls for Action on Key Elements
9 July 2025
The International Generic and Biosimilar medicines Association (IGBA) welcomes the adoption of the WHO Pandemic Agreement at the 78th World Health Assembly in May 2025. This landmark accord represents a critical step toward strengthening global […]
Bridging the Gap: The Public vs. Private Sector Divide in South Africa’s Healthcare System
18 June 2025
South Africa’s healthcare system presents a striking paradox—while universal access is a constitutional right, the availability and quality of services differ dramatically between the public and private sectors. This divide is particularly pronounced in the […]
Medicine Pricing in South Africa – Are We Paying Too Much?
28 May 2025
The question of whether South Africa is paying too much for medicines continues to spark debate across public health, policy, and economic circles. Medicine pricing is a complex issue shaped by regulatory frameworks, market dynamics, […]
The Role of Generic and Biosimilar Medicines in Reducing Healthcare Costs
7 May 2025
The rising cost of healthcare is a global challenge, with medication expenses making up a significant portion of total healthcare spending. Generic and biosimilar medicines offer an effective solution by providing high-quality alternatives to brand-name […]
IGBA Joins ICH Management Committee and Welcomes the Positive Vote of the General Assembly
10 April 2025
Kobe, Japan (June 7, 2018) The International Generic and Biosimilar Medicines Association (IGBA) very much welcomes today’s decision of the ICH General Assembly to elect the IGBA as a Management Committee Member of the International […]
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, […]