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FDA Approval of Renflexis, a Biosimilar to Remicade
As of the 24th April 2017, the US Food and Drug Administration has approved Samsung Bioepis’ biosimilar version of Remicade (infliximab). The Biologics License Application (BLA) for the infliximab biosimilar candidate, Renflexis (SB2), was submitted to the FDA in May 2016. Infliximab is a chimeric monoclonal antibody administered intravenously, that is used for treating several […]
Complex Drug Products and their Generic Counterparts
At the New York Academy of Sciences’ symposium on Equivalence of Complex Drug Products: Scientific and Regulatory Challenges, regulatory officials described how agencies approach evaluating complex generics for marketing approval. In 2015, almost 90% of prescriptions in the United States were for generics, according to the Generic Pharmaceutical Association. However, there are certain complex drug […]
Filgrastim Biological Shows Similar Efficacy to Originator
A clinical study comparing two formulations of filgrastim for controlling chemotherapy-induced neutropenia has shown that the efficacy and safety profile of the test drug were similar to those of the originator product. Neutropenia is one of the most common chemotherapy-related adverse events, and in severe cases, places patients at high risk of serious infection with […]
The Importance of Detecting Counterfeit Medicines
False medicines can present a huge health risk to the public. As well as potentially damaging the reputations of pharmaceutical companies, they can disrupt comparator sourcing and clinical trials services. The number of illegitimate and counterfeit medicines across the globe is becoming increasingly concerning, as they have even been appearing in the legitimate medical supply […]
Sourcing for Clinical Trials and Biosimilar Development
Clinical trial supply is, to state the obvious, an expensive and multifaceted activity which continues to get more complex. Over the past 5 years, factors have extended this trend; for example: Changes in and development of legislation – New EU Clinical Trial regulations (No 536/2014), the Falsified Medicines Directive, US FDA Drug Supply Chain Security […]