The first domestic qutod bead singular resistance was approved for listing in the European Union.

In May 2020, the European Medicines Agency (EMA) Commission for Human Medicine products (CHMP) following a series of rigorous reviews of the Zercepac ® and recommended ec approval of Zercepac ®'s listing license application. "In accordance with EU requirements for biosimilars, the Zercepac ® has a structure, purity and biological activity that is highly similar to the reference drug Herceptin ®," according to the final review decision published by the
EMA.
, clinical studies in patients with HER2-positive metastatic breast cancer showed that the ® Zercepac was equivalent to the clinical efficacy of Herceptin ®.
these data are sufficient to demonstrate that Zercepac ® have similar efficacy and safety to approved indications.
with the approval of HLX02 (Zercepac ®) in Europe, its commercialization will be handled by Accord and will be available for sale in all EU member states as well as in the European Economic Area countries norway, Iceland and Liechtenstein.
estimates that sales of the original tolubarbital monovironid suprem and its biosimilars in the European Union and Norway, Iceland and Liechtenstein reached US$1.37 billion in 2019, according to IQVIA MIDASTM data.
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