The
pioneering leader
in biosimilars

The
pioneering
leader in
biosimilars

 

 

 

 

What are biosimilars?

Biosimilars

A biosimilar is a type of biological product that is licensed by the FDA because it is highly similar, notwithstanding minor differences in clinically inactive components, to a biological product that is already FDA-approved. This originally approved product is known as the biological reference product (or reference product), and the biosimilar has been shown to have no clinically meaningful differences in potency, safety, and purity compared with that of its reference product.

Sandoz has more than 35 years of experience in the large-scale production of high-quality biologic products.

1980

 

Sandoz develops one of the first recombinant proteins.

1996

 

Sandoz pioneers the biosimilar development program.
Sandoz and Ciba merge to create Novartis.

2006

 

Sandoz launches the first product approved under the European Union's new regulatory pathway for biosimilars.

2014

 

Sandoz is the first to file under the new US FDA biosimilar approval pathway, leading to the first US-approved biosimilar.

2015

 

Sandoz receives approval of the first biosimilar in the US.

2016

 

Sandoz receives approval for its second biosimilar in the US, becoming the only company with 2 FDA-approved biosimilars.

Sandoz now provides biosimilars to over 75 countries worldwide.