Kelly Davio

May 23, 2018

On Tuesday and Wednesday, during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Maryland, researchers from Europe addressed the fact that, while biosimilars have a longer history in the European marketplace than they have in the United States, challenges to uptake still linger.

May 22, 2018

In a Monday workshop held at the International Society for Pharmacoeconomics and Outcomes Research’s 23rd Annual International Meeting, in Baltimore, Maryland, Mike Blum, MD, MPH, deputy director in the Office of Pharmacovigilance and Epidemiology at FDA, addressed the role of postmarketing surveillance in the US biosimilars market and the potential role of real-world evidence in interchangeable designations for biosimilars.

May 21, 2018

Today, at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting, held in Baltimore, Maryland, researchers addressed the complexities of using anti–tumor necrosis factor (anti-TNF) therapy in patients with rheumatoid arthritis (RA).

May 18, 2018

Given reliance on industry fees to pay for the review of medicines, as well as the pharmaceutical industry’s potential inability to sustain the level of fees required to review all new medicines without cooperation with the European Medicines Agency (EMA), the United Kingdom could have to reduce the number of drug marketing authorizations it grants each year, or raise the funds elsewhere.

May 17, 2018

Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.

May 17, 2018

The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.

May 16, 2018

Data from new CMS dashboards reveal that many of the drugs that have seen the highest annual growth in spending per beneficiary over the 2012 to 2016 period are products that either currently face or will soon face biosimilar or follow-on biologic competition.

May 15, 2018

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.

May 15, 2018

Drug maker Pfenex has announced positive top-line results from a phase 3 study that showed comparable overall profiles between reference teriparatide (Forteo) and Pfenex’s proposed follow-on, PF708, in patients with osteoporosis. Teriparatide, a recombinant human parathyroid hormone, is an anabolic agent that stimulates bone formation.

May 15, 2018

At the 58th Annual Scientific Meeting of the British Society for Haematology, held from April 16-18, 2018, in Liverpool, United Kingdom, researchers from 2 hospitals reported on the use of biosimilar rituximab in real-world settings.