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China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers

pharmafile | August 18, 2020 | News story | Manufacturing and Production, Sales and Marketing China, Henlius, Herceptin, Roche, biosimilar 

China’s National Medical Products Administration (NMPA) has given the green light to Shanghai’s Henlius for its biosimilar version of Roche’s Herceptin (trastuzumab) known as HLX02 for the treatment of HER2-mutated cancers.

Specifically, the therapy will now be available for use in the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, just like its reference product.

The approval comes after Henlius’ biosimilar was shown in preclinical, Phase 1 and Phase 3 studies to be highly comparable to Roche’s Herceptin in terms of safety, quality and efficacy.

“HLX02 is the second product successfully approved for launch of Henlius and the first product that has received recognition from an international drug regulatory agency,” commented Wenjie Zhang, President of Henlius. “We hope that HLX02 will benefit HER2-positive breast cancer and gastric cancer patients both in urban and rural areas in China.”

The drug was also awarded approval, under the brand name Zercepac, in Europe last month, where it was also the first China-developed therapy of its kind to secure marketing authorisation in the region.

Matt Fellows

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