Kelly Davio


Many Injectable Essential Medicines Have Prices Substantially Higher Than Estimated Cost-Based Prices

November 30, 2019

Universal access to affordable essential medicines remains an unmet goal, and while the World Health Organization has been attempting to address this problem through prequalification of drugs like insulin to help ensure access for patients in low-resource areas, costs for many products remain prohibitive.

New Data Help Delineate the Role of Biosimilar Infliximab and JAK Inhibitors in Pediatric IBD

November 29, 2019

Data on the safety and efficacy of biosimilar infliximab CT-P13 (Inflectra, Remsima) in treating inflammatory bowel disease (IBD) continue to accrue, in both adult patients and in pediatric patients, and a study from Finland adds to that body of knowledge, while another study in pediatric patients shows that Janus kinase (JAK) inhibitors may be an option for those who do not respond adequately to infliximab or other biologic treatment.

Biosimilar Business Roundup: November 2019

November 29, 2019

During November, biosimilar developers announced a spate of new business agreements and acquisitions. November also saw biosimilars approved and launched, and innovator products’ sales slipping.

Subcutaneous Formulation of Celltrion's Biosimilar Infliximab Authorized by European Commission

November 26, 2019

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

FDA Releases Draft Guidance on Insulin Biosimilars, Interchangeable Insulins

November 25, 2019

The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

Nordic Study Shows Similar Retention Rates for Biosimilar and Reference Etanercept, Infliximab

November 25, 2019

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

Newly Reported Phase 3 Data Support Biosimilarity of HLX02 and Reference Trastuzumab

November 25, 2019

During the European Society for Medical Oncology Asia Congress 2019, held last week in Singapore, a research team led by Binghe Xu, MD, PhD, department of medical oncology at the Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, reported that the biosimilar met its primary end point of best overall response rate at week 24.

Sandoz Execs Reflect on a Decade of Experience With the BPCIA, Look to Biosimilars' Future

November 22, 2019

In an interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.