Future Biosimilars Will Be a Risky Business, Says Norway's Steinar Madsen, MD
March 25th 2019During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.
Rethinking the Patient Perspective on Biosimilars
March 22nd 2019Often left out of the discussion about switching to biosimilars is the perspective of a particularly key stakeholder group: patients. During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21-22 in Porto, Portugal, Francois-Xavier Frapaise, MD, principal of F.-X. Frapaise Consulting, sought to describe current challenges and emerging solutions in gaining patients’ trust in biosimilars and suggested that biosimilars can be an opportunity to “resuscitate the social contract.”
An Expert View on Immunogenicity and Biosimilars
March 22nd 2019During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.
Global Biosimilars Require Regional Development Approaches
March 21st 2019While much attention is paid to the US and European biosimilars markets and the benefits that biosimilars could accrue for patient access and cost reduction, other large regulatory jurisdictions, including those with limited healthcare resources, could also benefit from these products. However, bringing biosimilars to countries outside of European Medicines Agency (EMA) or FDA authority has its unique challenges.
Regulator Explains How Denmark Has Achieved Its Biosimilar Success
March 21st 2019Nikolai C. Brun, MD, PhD, chief medical officer and director of the division of medical evaluation and biostatistics at the Danish Medicines Agency, shared how his national agency has actively worked to adopt and benefit from biosimilars, and provided a clear reminder of the fact that biosimilar uptake does not occur without concerted effort on the part of stakeholders.
More Than a Decade After the First Biosimilar, the Regulatory Landscape Is Increasingly Complex
March 21st 2019During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.