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Quality and Laboratory System In my earlier post, I described the techniques and approaches that are currently being used to inspect international firms who are importing products to USA or Europe. Continuing with my original format I will try to compare the different methodologies used by FDA and EU inspectors to conduct Quality and Laboratory […]

FDA Responsibility –  Is there inspectional approach differences for International companies by FDA ? Most can agree that regulating the safety and effectiveness of drugs and medical devices is for the protection of public health and we applaud the regulatory agencies who work tirelessly to make this possible. Our company has participated in many inspections with our […]

As part of our role advising biosimilar clients, we have encountered both mature and budding companies who are trying to either extend their portfolio or enter the biosimilars space. These companies often ask us to help them with the evaluation of either an existing process that has been launched in semi-regulated markets or the evaluation […]

10 Lot Dilema The core to establishing analytical similarity is creating a statistically valid package that shows the reference product is statistically the same as the biosimilar candidate. In order to evidence and show analytical characterization FDA recommends a three tier approach which requires the procurement and comparative testing of at least 10 lots of […]

The FDA has recently published a draft guidance for establishing interchangeability, which will allow a biosimilar drug to be used without permission from a physician. This guidance is very complex and has many facets. We attempted to create a simplified version of it and highlighting some of the key points. The reader is requested to […]

Role of Agency – Protect Patient Safety The FDA is mandated to regulate that drugs that are approved are safe and efficacious and do not posed any risk to patient health. Biosimilars have a slight different starting point since most of the molecules have been shown to be safe and effective for decades. Why does […]