Kelly Davio

September 19, 2018

The State of California has filed suit against drug maker AbbVie, alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name adalimumab, Humira, and used a network of registered nurses to mislead patients about the risks associated with the drug.

September 18, 2018

The bill, introduced in March 2018 by Senator Susan Collins, R-Maine—together with Senators Claire McCaskill, D-Missouri, and Debbie Stabenow, D-Michigan—eliminates so-called “gag clauses” that prevent pharmacies from telling consumers whether they could spend less on their medication by paying out-of-pocket.

September 18, 2018

The improved efficacy of a biologic drug in combination with a conventional treatment in rheumatoid arthritis (RA) has been well demonstrated, but some biologic-naive patients are unable to tolerate drugs such as methotrexate. Limited data are available about which biologic to select for monotherapy in such patients, however.

September 12, 2018

Two pivotal studies of biosimilar epoetin alfa (Retacrit) versus its reference (Epogen) in patients undergoing hemodialysis have shown that the biosimilar and the originator have comparable safety and efficacy. In the phase 3b PIEDA (Phase 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm) study, investigators sought to further investigate how switching from the reference to the biosimilar affects maintenance of hemoglobin levels when using an erythropoiesis-stimulating agent dosing algorithm.

September 11, 2018

The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

September 10, 2018

“Biosimilars offer incredible health and economic opportunities in the United States, but unless substantial barriers are surmounted, these opportunities will not be fully realized,” say the report's authors.

September 09, 2018

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

September 07, 2018

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

September 06, 2018

The European Union already has far more approved biosimilars—45 products referencing 15 medicines—than does the United States, but as a newly released report from IQVIA states, the number of European biosimilars available today represents just a fraction of what the market is expected to contain in the coming years, raising questions about the sustainability of the market.

September 06, 2018

Writing in the European Medical Journal, Anna La Noce, MD, PhD, and Marcin Ernst, MD, MBA, explain that much confusion about switching between biosimilars and reference products in the United States versus in the European Union arises from different uses of the term “interchangeability.”