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.

« View all Federal Issues