Generic products can be safe, effective, and lower cost alternatives to brand name drugs. Therefore, they’re important to reduce healthcare costs and increase the access to medicines. Since the clinical trial data supporting the safety and efficacy of the active pharmaceutical ingredient (API) is already available and approved for the Read more…
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. -FDA If you want to bring a biosimilar to market, you’ll need to demonstrate that it is highly similar to the reference product in both structure and Read more…
The success of a globalisation strategy relies on a key pillar: process and product performance comparability. This is so because global pharma companies require flexibility to produce the same product across a network of manufacturing sites and locations. For this blog post, we’re going to offer our perspective on how to handle Read more…
Regulators expect sound Quality Risk Management in the field of Comparability. And this, despite the fact that the ICH Q5E, the key guideline on comparability, was published before the ICH Q9 on Quality Risk Management. This blog post will give you some considerations on Quality Risk Management and how it applies to Read more…
During biopharma process development, there are often process changes that occur between non-clinical and clinical phases. When it comes to early development stages, Comparability Studies can be challenging. If you are facing this type of problem, we’ve got the perfect reading for you! This blog post goes over the key aspects of developing solid comparability assessments Read more…
Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts in biologic development. These concepts are helpful to compare biosimilar and reference products. But they can go beyond Read more…