A biosimilar is a type ofthat 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 develops one of the first recombinant proteins.
Sandoz pioneers the biosimilar development program.
Sandoz and Ciba merge to create Novartis.
Sandoz launches the first product approved under the European Union's new regulatory pathway for biosimilars.
Sandoz is the first to file under the new US FDA biosimilar approval pathway, leading to the first US-approved biosimilar.
Sandoz receives approval of the first biosimilar in the US.
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.
A biologic is a product derived from a variety of sources (human, animal, or microorganism) and may be produced by biotechnology methods and other cutting-edge technologies. Some biologics manufactured today include vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins.