Kelly Davio

April 01, 2019

Approval of biosimilars in indications for which they were not studied directly in phase 3 clinical trials relies on the extrapolation of indications, a concept that is scientifically justified but, nevertheless, has generated some concerns among clinicians. In the case of biosimilar infliximab CT-P13 (Inflectra, Remsima), some gastroenterologists have voiced a lack of confidence in the biosimilar for the treatment of inflammatory bowel disease, including Crohn disease (CD) and ulcerative colitis. Now, head-to-head study, published in The Lancet, has produced data that may help allay those worries.

April 01, 2019

Daiichi Sankyo has announced that it is accelerating its Biologics License Application (BLA) for DS-8201, [fam-] trastuzumab deruxtecan for the treatment of patients who previously received ado-trastuzumab emtansine (Kadcyla), to the first half of 2019.

March 29, 2019

Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.

March 29, 2019

During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.

March 28, 2019

During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a group of experts addressed successes, challenges, and learnings from biosimilar procurement processes.

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.

March 27, 2019

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

March 26, 2019

The FDA's updated guidance on the naming of biologics, biosimilars, and interchangeable products has caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.

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.

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.