November 03, 2014 - Today the RAND Corporation projected that the introduction of biosimilar drugs in the US will reduce direct spending on biologics by USD 44.2 billion from 2014 to 2024. Currently there are no biosimilars approved by the FDA for use in the US. Products submitted for review by FDA through the Biologics Price Competition and Innovation Act pathway are developed with highly similar quality, safety and efficacy to marketed biologics, but they come at a lower price. A biosimilar will be approved if and only if it is so similar to the originator biologic product that statistically you can’t tell the two apart in terms of ability to treat the disease, safety profile and overall quality: the three things that matter the most to doctors and patients.
Against the backdrop of a health care system in which biologic medicines play an increasingly prominent role, the new “Perspective” published by RAND and sponsored by Sandoz is the latest to highlight the promise of intended biosimilars in creating healthy competition in the biopharma marketplace, which can ultimately benefit patients, care providers, and the people who pay for health care.
While it is difficult to pinpoint exact savings associated with the advent of biosimilars in the US, we do know that USD 100 billion worth of biologics are expected to be off patent by 2020. Sandoz is committed to bringing FDA-approved biosimilars to the US market, putting breakthrough medicines in reach for millions of people.