Unknowns of interchangeability likely not problematic with monitoring, FDA guidance

July 27, 2017
As more biosimilars are approved by the FDA, and with more in the development pipeline, the issue of interchangeability is raising red flags and…

Patient access, health care cost reduction spur biosimilars development

July 27, 2017
The main rationale for regulations that encourage development of biosimilars is, in brief: biologics are expensive. Relative to the total market…

Physicians cautiously optimistic as they gain knowledge of biosimilars

July 26, 2017
Although research has shown that biosimilars complement the biologic armamentarium for managing chronic diseases, concerns regarding their…

Path to approval: How biosimilars are developed, approved in the US

June 30, 2017
As part of the Biologics Price Competition and Innovation Act of 2009 within the Affordable Care Act, an abbreviated licensure pathway was developed…

Biosimilars: Why now? Why not?

June 29, 2017
“If we want things to stay as they are, things will have to change.”

Understanding the abbreviated licensure pathway: Q&A with FDA's Leah Christl

June 29, 2017
To clarify some of the procedural details and concerns surrounding the abbreviated licensure pathway for biosimilars, Healio spoke with Leah

Biosimilar terms you should know

June 28, 2017
“Biosimilars” are a relatively new concept to many physicians in the U.S., and an extensive inventory of associated terminology may be…

The basics of biosimilars

June 28, 2017
Biosimilars are developed under the Biologics Price Competition and Innovation Act The Biologics Price Competition and Innovation Act, signed…

Biosimilar to Enbrel approved in Europe

June 27, 2017
Erelzi, a biosimilar to Enbrel, has been approved by the European Commission for all indications of the reference product, according to a company…
FDA News

FDA rejects Pfizer's Epogen biosimilar for anemia

June 26, 2017
The FDA rejected Pfizer’s biologics license application for its proposed biosimilar to epoetin alfa for the treatment of anemia from various…