Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
Chinese biosimilar maker Shanghai Henlius Biotech Inc. won EMA approval for its Zercepac, a biosimilar to Roche Holding AG’s Herceptin (trastuzumab) on July 28. Henlius CEO Scott Liu told BioWorld that Zercepac will be the first Chinese monoclonal antibody biosimilar to enter the EU market, setting a precedent for Chinese drugmakers seeking to join the global race in biosimilars.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.
HONG KONG – Prestige Biopharma Pte. Ltd., a Singapore-headquartered pharmaceutical company under the Prestige Group, has agreed to grant exclusive license to U.K.-based multinational company Mundipharma International Ltd. for distribution and sale of its trastuzumab biosimilar, Tuznue, in western European markets, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.
