Biosimilars
The Issue
Drugs developed through biotechnology differ from traditional small molecule chemical drugs. They are "biologics" that are complex medicines manufactured using living organisms. Biosimilars, also known as follow-on biologics are products that are similar to, but not the same as, an innovative new drug. They are not generic drugs, which are products shown to be the same as an innovative drug and generally designated as therapeutically interchangeable.
Our Position
Any laws allowing or regarding biosimilars must protect patient safety and preserve incentives to innovate. Due to their size and complexity, biologics generally cannot be scientifically characterized to the same degree as small molecule chemical drugs using existing science.
Any approval of these drugs must be based on the same rigorous standards applied to pioneer biotechnology products.
About MassBio
MassBio, founded in 1985, is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Latest Updates
- July 28, 2010 *Newly Revised* Overview of Clinical Research Course - Fall 2010 Program
- July 28, 2010 MassBioEd Course: Two Day Leadership Training Program for Scientists
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- July 20, 2010 Joule Names John Ward Senior Vice President of Production