The Frontier of Biosimilars

Meeting the need for increased access

Biologic drugs have transformed the treatment of cancer, autoimmune diseases and other illnesses, but they have also driven up healthcare costs. Biosimilars can help control spending while delivering high-quality care.

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Biologics versus small molecules: the heart of the challenge

The majority of all drugs are chemical compounds, sometimes referred to as small molecules. Biologics, in contrast, are large, complex molecules created from proteins and other cell structures. How large is large? Antibody proteins that are the basis of many biologics may have 20,000 atoms, while aspirin, a typical small molecule, has just 21.

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FUNDAMENTAL DIFFERENCES EXISTS BETWEEN CHEMICAL DRUGS AND BIOTECH MEDICINES

The differences between biologic and chemical drugs aren’t just in size. And the differences make it much harder for biosimilar companies to establish that their products perform just like the original branded biologics. Small molecule drugs have a molecular structure that’s easier to analyze, compared with drugs made of proteins and protein fragments. That means makers of generics are able to guarantee that their chemical products have exactly the same active chemical ingredients as branded drugs, and can be taken in the same doses.

Likewise, the biological and chemical manufacturing processes couldn’t be more different. Biologics are produced in living cell cultures – a challenging and expensive process, especially when the medicines are produced at commercial scale. Because the production process itself is a cell line – and each cell line is unique – the biosimilar is never identical to the branded product, though structural and functional similarity are the goal.

For all these reasons, makers of biosimilars face higher technical, regulatory and marketing hurdles, compared with generics makers who follow a well-trodden path. Success, for biosimilars companies, hinges on having the necessary scientific assets, clinical insights, industry relationships and understanding of the fast-changing global regulatory environment. These are the very qualities that position Coherus for success in the biosimilar market.