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Super-blockbuster: Trastuzumab

may 14, 2019 By 1℃

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

Super-blockbuster: trastuzumab

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:

Trade name

Enterprise

Approval time

Ogivri

Mylan

Dec. 11, 2018

Trazimera

Pfizer

July 26, 2018

Kanjinti

Amgen

May 15, 2018

Herzuma

Celltrion

Feb. 7, 2018

Ontruzant

Samsung Bioepis

Nov. 15, 2017

Trastuzumab biosimilars approved for marketing in the U.S.

Trade name

Enterprise

Approval time

Ogivri

Mylan/Biocon

Dec. 1, 2017

Herzuma

Teva/Celltrion

Dec. 14, 2018

Ontruzant

Samsung Bioepis

Jan. 18, 2019

Trazimera

Pfizer

Mar. 11, 2019

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 3rd 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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