Life in the Era of Follow On Biologics

Co-authored by Dr. Boris Reznik, Chairman and CEO of Biorasi and Dominique James, Research and Editorial Analyst

The pharmaceutical industry was changed forever in 1982 when the first biologic was introduced to the market. Novel biologics revolutionized the treatment of many life threatening and debilitating diseases. Now, over 30 years later, it is time for follow-on biologics to bring the revolution to the industry. Follow-on biologics (biosimilars, biobetters, interchangeables) and “follow-on drugs” (505(b)(2), 505(j)/ ANDA) share a key similarity, they allow for more cost effective development within a shorter time frame. Pharmaceutical companies are able to save BIG on producing follow-on drugs. Those big savings, at the top of the pyramid, create vital savings for the large consumer base. Generic pharmaceuticals represent a significant part of small-molecule drug revenue, and biosimilars will soon make their own lasting mark on drug sales.

This change and growth in the industry is incredible. And it’s coming fast. Biorasi has uniquely positioned themselves to lead in the era of biosimilars. Four key factors of our history, and who we are as a team, interact to create Biorasi’s advantageous industry niche.

1. Biorasi has run as many biologics trials as they have small-molecule drug trials; a standout feature of our study experience that makes us different from other CROs.
2. Biorasi experts have been well-known leaders in the biologics field for decades, adding invaluable knowledge to our team.
3. Biorasi, with “follow-on small molecule drugs” being our industry focus, has earned an understanding of the unique peculiarities of follow-on drug discovery, development, manufacturing, and marketing.
4. Biorasi added to their Clinical Research Optimized™ platform, TALOS™, with a special release dedicated to biosimilars trial management.

The inimitable combination of biologics knowledge and follow-on trial experience has poised Biorasi to be a natural leader in this new era of biologics.

Our opening act? Biorasi ran four of the first biosimilars trials in the United States under the new guidelines.