Generic & Biosimilar Insights
Strengthening Medicine Security:
The Role of Supply Chain Diversification in a Changing Global Market
Medicine supply chains have become increasingly interconnected, linking manufacturers, raw material suppliers, logistics providers, regulators, and healthcare systems across...
Medicine Quality Beyond Approval:
Understanding Ongoing Monitoring and Product Lifecycle Management
The approval of a medicine by a regulatory authority is often viewed as the final step before it becomes available to patients. In reality, regulatory approval marks the...
How Generics and Biosimilars
Support Long-Term Treatment Sustainability
Chronic diseases continue to represent one of the most significant healthcare challenges globally and within South Africa. Conditions such as diabetes, hypertension,...
Data, Traceability and Safety:
How Medicines Are Tracked Across Their Lifecycle
Every medicine follows a carefully monitored journey from the starting point in manufacturing to patient use. Behind the scenes, a network of quality systems, traceability...
Molecule to Market:
How Innovation Translates into Biosimilar Development
Biosimilars have become an increasingly important part of modern healthcare, particularly as healthcare systems seek to expand access to advanced therapies while maintaining...
Pricing, Value and Volume:
How Generics and Biosimilars Sustain Access in a Constrained Healthcare Environment
Healthcare systems globally continue to face increasing pressure from rising treatment demand, constrained healthcare budgets and growing chronic disease burdens. In South...
Winter Demands and Generics:
How Seasonal Illness Shapes Medicine Supply and Substitution
As winter approaches in South Africa, healthcare systems typically experience a noticeable increase in demand for medicines linked to seasonal illness. Respiratory infections,...
Pharmacist Adoption of Generics and Biosimilars: Supporting Access and Confidence
Pharmacists play a central role in how medicines are used at the point of care, particularly in the adoption of generics and biosimilars. While regulatory authorities ensure that...
Trusted Through Standards: How GBMSA Members Uphold Quality, Safety, and Reliability in Medicines
Confidence in medicines is built over time through consistent quality, reliable supply, and adherence to well-defined standards. In South Africa, manufacturers represented within...
Cold Chain and Critical Care: Why Storage and Transport Matter More Than We Think
The quality and effectiveness of many medicines depend not only on how they are manufactured, but also on how they are stored and transported throughout the supply chain....
From Prescription to Patient: Understanding the Journey of a Medicine in South Africa
The availability of medicines at facility level is the result of a structured process that spans multiple stages, from regulatory approval through to final dispensing. Each step...
Building Confidence in Generics and Biosimilars: The Role of Patients in Strengthening Sustainable Access
Access to medicines is shaped not only by regulatory frameworks, pricing structures, and supply systems, but also by how medicines are understood and accepted by the people who...
Industry Updates
Bridging Innovation and Access: Rethinking the Role of Regulatory Systems in a Resilient Healthcare Future
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...
The Power of Education: How Healthcare Providers Can Help Patients Understand the Safety and Efficacy of Generics and Biosimilars
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...
Navigating Regulatory Hurdles: How SAHPRA is Streamlining Approvals for Generics and Biosimilars
Efficient regulatory processes are essential to ensuring that safe, effective, and affordable medicines reach patients without unnecessary delays. In South Africa, the South...
The Role of Generic and Biosimilar Medicines in Managing Chronic Conditions in South Africa
South Africa faces a growing burden of chronic diseases, including diabetes, hypertension, cancer, HIV/AIDS, and rheumatoid arthritis. As treatment regimens become more complex...
Breaking Down the Basics: What are Biosimilars and How Do They Differ from Generics?
Biosimilars and generics both play an important role in expanding access to affordable medicines, but they differ significantly in structure, manufacturing, and regulatory...
The Road Ahead: Strategic Recommendations for Equitable Access to Medicines
As South Africa navigates the complexities of medicine access, ranging from regulatory delays and affordability to supply chain disruptions and governance, there is growing...
Human Capital and Governance in Medicine Access
Exploring workforce gaps, training, and institutional oversight A resilient health system is built not only on infrastructure and resources but critically on skilled human...
Strengthening Local Pharmaceutical Manufacturing and Supply Security
Aligning Industrial Strategy with Health Access Needs South Africa’s dependence on imported pharmaceutical products poses significant challenges to medicine security, pricing...
Policy Levers That Matter: Key Health System Interventions for Long-Term Access
Access to medicines in South Africa is shaped by a complex intersection of regulatory frameworks, procurement mechanisms, pricing structures, supply chain logistics, and human...
Control of Solid-State Characteristics of the Active Pharmaceutical Ingredients: Particle Size Distribution
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...
Policy & Regulation
In Support of Global Comparator for Biosimilars Waiving bridging studies concerning local versus global reference products
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...
IGBA position on Streamlined Development
Position: Today’s regulatory science supports the development of biosimilars based on analytical (physicochemical and functional) data and a clinical pharmacokinetic study (which...
Healthcare Innovations
Regulatory Delays and Market Entry Barriers: A Bottleneck to Equitable Medicine Access in South Africa
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....
Addressing Medicine Accessibility in South Africa
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...