Is The Biosimilar for Roche’s Herceptin A Major Threat?

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Mylan and Biocon Ltd have completed a Phase III study for biosimilar version of Roche’s Herceptin, which showed promising results. It was found that there was no significant difference between the two drugs in treating breast cancer.  The objective response rate was 69% for the biosimilar as compared to 65% for Herceptin.  With small molecule drug therapies, generic drugs are exact chemical copies of the original drug.  With large molecule therapies, which are often large proteins, only the therapeutically actice portions of the molecule are copied, as it is infeasible to recreate the whole moelcule. Hence, they are called bisimilars, rather than generics. Biosimilars have only just started to break into the U.S. market, while they have been in the European market for several years. Other biosimilars for breast cancer are being developed by Pfizer, Celltrion, Amicod and Actavis.  We expect a moderate revenue decline in the sales of Herceptin due to biosimilar competition.

Roche-herceptin

 

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Notes:

1) The purpose of these analyses is to help readers focus on a few important things. We hope such lean communication sparks thinking, and encourages readers to comment and ask questions on the comment section, or email content@trefis.com
2) Figures mentioned are approximate values to help our readers remember the key concepts more intuitively. For precise figures, please refer to our complete analysis for Roche

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