Articles The Interchangeability and Substitutability Conundrum: Time for Convergence The first blog post for this year was on interchangeability. In it I announced that…Cipla South AfricaJanuary 20, 2024
Articles Setting specifications for Dissolution of Immediate Release Solid Oral Dosage Forms The importance of the biobatch The approval of Rybelsus®, which contains the GLP-1 agonist, semaglutide, by the EMA in April…Cipla South AfricaNovember 11, 2023
Articles Control of Solid-State Characteristics of the Active Pharmaceutical Ingredients: Polymorphism In the first post in this series on pharmaceutical specifications, I mentioned that characteristics or…Cipla South AfricaSeptember 1, 2023
Articles The IGBA CEO Advisory Committee: Four Keys to More Predictable Supply Chains Vienna, June 14, 2023 – The COVID-19 pandemic demonstrated the critical importance of resilient global…Cipla South AfricaJuly 7, 2023
Articles Has the time for Local Biosimilar Development Finally Arrived? Several attempts have been made in the past ten years or so to establish a…Cipla South AfricaJune 30, 2023
Articles Nitrosamine Impurities: Are they a Major Concern for Biologics? Nitrosoamine impurities have been a major concern to regulators and the pharmaceutical industry since 2018…Cipla South AfricaMay 5, 2023
Articles The Often Overlooked Constraint to Local Biosimilar Industry Development: Expert Human Resources It is widely acknowledged that South Africa needs its own biosimilar manufacturing industry, and in…Cipla South AfricaMarch 30, 2023
Articles SAHPRA’s Reliance-Based Evaluation Pathway for Rapid Review and Registration: Problems and Opportunities The SAHPRA, like many other developing country regulatory authorities with capacity constraints, has implemented in…Cipla South AfricaMarch 2, 2023
Articles New Position of SAHPRA on Interchangeability After months of writing about it, and even raising the issue among regulatory stakeholders, SAHPRA…Cipla South AfricaFebruary 23, 2023
Articles Do-It-Yourself Biomanufacturing: The Potential Consequence of Regulations and Market Forces that make Medicines Expensive I have written before about insulin – a simple biologic with arguably the least stringent…Cipla South AfricaDecember 8, 2022
Articles Non-Biological Complex Drugs: Time for a special guideline for the registration of follow-on versions of this class of medicines https://www.youtube.com/watch?v=ITO49g5BO9A Non-biological complex drugs (NBCDs) represent a class of diverse synthetic drugs midway between conventional…Cipla South AfricaNovember 9, 2022
Articles The Biosimilars Guideline: Opportunity for Revision From the desk of Henry Leng – In my post of three months ago (published…Cipla South AfricaSeptember 14, 2022