FDA approves Mylan's biosimilar of Roche's cancer drug Herceptin


Amgen/Allergan, Pfizer, and Samsung Bioepsis are also developing biosimilar Herceptin products for the USA and global markets, but analysts have suggested that Roche's brand will not see a dramatic reduction in sales after the rivals launch, in part because use of the drug in combination with newer HER2 drug Perjeta (pertuzumab) is on the rise.

The US Food and Drug Administration (FDA) on Friday approved the first biosimilar to Roche's blockbuster breast and stomach cancer drug Herceptin (trastuzumab).

The American regulator has approved Ogivri for all indications of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.

This is the first US/EU biosimilar approval for the partnership, allaying concerns over compliance with manufacturing standards, potentially paving the way for Biocon's biosimiliar of chemotherapy drug Neulasta in Q1 2018, according to Kotak Securities analysts. The biosimilar trastuzumab or Ogivri is one of the six biologic products co-developed by the companies.

Shares of Biocon hit a record high on US FDA approval for generic cancer drug Ogivri.

First approved in the United States in 1998, Herceptin had USA sales of more than $2 billion for the 12 months ending 30 September 2017, according to IQVIA.

Biocon was the pick of the week as the company's partner Mylan got the US FDA's approval to market cancer biosimilar Trastuzumab in the US market.

"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the U.S. healthcare system", remarked Mylan's CEO Heather Bresch. It is already approved in 19 countries around the world, including India.