Super-blockbuster: Trastuzumab

There have been 5 trastuzumab biosimilars successively marketed in Europe and the U.S. so far, wherein, 5 have been approved for marketing in the EU and 4 in the U.S. See my previous article A Review of the Biosimilars Approved in the EU and U.S. for the details.

Also read: Based on China to Go International: The Trastuzumab Biosimilar HLX02 Applied for Marketing

Originally developed and marketed by Roche, trastuzumab was first approved for marketing in Sep. 1998 in the U.S. As one of the three super-blockbusters of Roche, trastuzumab has accumulatively brought over CHF80 billion sales revenue.

Herceptin (trastuzumab) entered China in 2002 and has now entered China’s national medical insurance drug catalog and 2018 Edition National Essential Drugs List of China. It is priced at RMB7,600 for the specification of 440 mg:20 ml, therefore, the payment pressure of patients is still heavy. The marketing of Henlius’ HLX02 will effectively relieve patients’ payment pressure.

There have been 5 trastuzumab biosimilars successively marketed in Europe and the U.S. so far, wherein, 5 have been approved for marketing in the EU and 4 in the U.S. See my previous article A Review of the Biosimilars Approved in the EU and U.S. for the details.

Trastuzumab biosimilars approved for marketing in the EU:

Trastuzumab biosimilars approved for marketing in the U.S.

The trastuzumab HLX02 will be based on China to go international. As mentioned above, Henlius has established cooperation with partners in many key markets in the world for the drug, to accelerate the internationalization process. The drug is the 3^rd biosimilar applied by Henlius for marketing following rituximab biosimilar and adalimumab biosimilar. Henlius has submitted the prospectus to HKEx on Dec. 14, 2018, and it will undoubtedly stand out to become a strong performer in China’s biosimilar field.

Related:

Based on China to Go International: The Trastuzumab Biosimilar HLX02 Applied for Marketing

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