In the News: When Will We See the Full Benefits of Biosimilars?

Monday, January 29, 2018

Since 2015, the healthcare industry has been tracking the progress and awaiting the wide-scale availability of biosimilars, a potentially more affordable alternative to biologic products. But the slow proliferation of these products continues to be the difficulty in getting them to market and navigating the many twists and turns of the regulatory and reimbursement process. These issues were discussed in the recent Drug Store News article, “Biosimilars poised to bring savings — if they get to launch”.

The DSN article notes that, despite projections of billions of dollars in potential savings from biosimilar drugs as biologics lose patent protections, the hurdles these drugs have to overcome to make it to market delay release, eat into potential profits, and keep patients from having access to treatments that may be priced 10-15% lower than their reference drugs.

Largely the obstacles these products face are legal, as biosimilars have to prove they are not violating the intellectual property rights of their reference products in order to secure approval. Litigation from the manufacturer of the reference product has impacted FDA approval and timing of release in several cases so far.

Other issues that complicate the approval of biosimilars include:

  • Naming conventions
  • Interchangeability of biosimilars with their reference products
  • Inconsistent payment rates for reimbursement

The article quoted a RAND report: “We must put the patient at the center of the FDA’s guidance for naming and interchangeability to reduce confusion and unreasonable requirements that ultimately impact patient access.”

Read the full Drug Store News article.

You may also like:

Blog Post

Pain management is an area of concern for many healthcare professionals, and not just because it’s so prevalent in the national news cycle. In her article “To tre...

View Blog Post
Blog Post

Because of the concern about prescription opioid abuse and the growing numbers of dependent opioid users switching to heroin, it is of interest to ascertain the rate and incidence of such transition. Accord...

View Blog Post
Blog Post

NCPDP, the standards development organization focused on the pharmacy sector, just wrapped up its annual business and technology conference, which immediately followed its quarterly technical ...

View Blog Post

RxPerts Academy

Stay in the Know

Sign up to start receiving notifications via email of our upcoming webinars!

Sign Up