PowerPoint Slides for: History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology

Background: Exogenous replacement of erythropoietin
(EPO) by recombinant human EPO has been considered a standard of care
for the treatment of anemia in patients with chronic kidney disease for
more than 20 years. Genetically engineered biologic proteins derived
from human, animal, or microorganism sources are a major area of growth
in modern medical care, accounting for one-third of new drug approvals
in the past decade. Despite benefit to patients, the use of biologics
comes at a significant cost, representing one of the fastest growing
segments of strained healthcare budgets around the world. Summary:
Biosimilars, or biologic drugs that are designed to be highly similar
to approved reference biologic drugs, have been available in Europe for
more than 10 years with no unusual or unexpected effects compared to
their reference biologics whose patents have expired. Given the success
of the biosimilar approval pathway pioneered in Europe, it has served as
a global reference for other regulatory authorities to establish and
implement biosimilar licensure frameworks, including the United States
(US), the largest pharmaceutical market in the world. Given 10 of the
top 25 drugs sold in 2014 were biologics, and considering the rising
costs of healthcare, biosimilars have the potential to become a
significant part of the US market. Key Messages: For the
nephrology community, the recent patent expiries for epoetin alfa
(Epogen®, Amgen and Procrit®, Johnson & Johnson) have created the
opportunity to develop biosimilar EPOs. And while no biosimilar in this
therapeutic class is approved in the US, there are proposed biosimilars
in development.