By Anna Rose Welch, Editor, Biosimilar Development
In a recent hearing on the implementation of the BPCIA, a lack of funding was pinpointed as a cause for the slow formation of the biosimilar approval pathway. While this is a likely scenario, this hearing continued to emphasize the overall lack of transparency over what else might be stalling the development of this pathway five years after the approval of the BPCIA.
By Ed Miseta, Editor, Clinical Leader
UPS's Pain in the Chain survey is one of the best ways to understand where life sciences companies stand on the issues making logistics a headache and keeping executives up at night. Since 2008, the survey of healthcare and life sciences supply chain professionals has attempted to determine the needs of these companies.
At the Biosimilars Clinical Studies And Analytical Similarity Summit we’ll be providing key insights from thought leaders into the biggest challenges in the analytical and clinical phases of biosimilar drug development, from responding to additional regulatory challenges, demonstrating the quality attributes needed to prove interchangeability and successfully execute cost-efficient clinical trials.