Latest Conference Articles

Fostering Biosimilar Policies for a Sustainable Future

Kelly Davio

March 28 2019

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

One Canadian Payer's Experience With Biosimilars

Kelly Davio

March 25 2019

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

Future Biosimilars Will Be a Risky Business, Says Norway's Steinar Madsen, MD

Kelly Davio

March 25 2019

During 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

Kelly Davio

March 22 2019

Often 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

Kelly Davio

March 22 2019

During 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

Kelly Davio

March 21 2019

While 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

Kelly Davio

March 21 2019

Nikolai 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

Kelly Davio

March 21 2019

During 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.

New Research Assesses Factors That May Impact Adalimumab Therapy in IBD

Kelly Davio

March 8 2019

During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).

2 New Studies Highlight Safety, Efficacy, PK of Subcutaneous CT-P13

Kelly Davio

March 7 2019

Celltrion, maker of biosimilar infliximab CT-P13 (Remsima, Inflectra), has recently submitted an application to the European Medicines Agency for a subcutaneous formulation of the biosimilar.