First China made biosimilar for breast cancer to be out soon

Trastuzumab, a drug used for breast cancer patients may shortly be available in its biosimilar form. A randomised phase -3 study of the first China manufactured biosimilar called 'H LX02' was reported at the European Society for Medical Oncology (ESMO) 2019 taking place in Singapore.

In the three day conference starting from November 22-24, the benefits of the biosimilar drugs were widely discussed by medical oncologists, pharma researchers.

Trastuzumab, was first approved for medical use in 1998 in USA. It's one of the drugs listed as essential drugs by the World Health Organization.

HLXO2, a biosimilar of Trastuzumab has been developed by Shanghai Helinus Biotech (Helinus) and has been evaluated by the European Medical Agency. It has also been reviewed by the National Medical Products Administration in China.

Biosimilars are medicinal products containing a similar version of the active substance of their biological originator or reference product and are derived from living organisms. The development of biosimilars offer a way of improving access to cancer treatments by increasing treatment options and reducing cost.

“Trastuzumab is not widely accessible around the world due to its high cost. The entry of more affordable versions of trastuzumab such as HLX02 could open up treatment access,” said study first author Dr Binghe Xu, Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.

The study results said that the rates of adverse events and treatment emergent adverse events were similar for HLX02 and reference trastuzumab and there were no differences in safety profiles or immunogenicity.“HLX02 is equally safe and effective as the reference trastuzumab and has been rigorously evaluated by regulatory authorities such as the European Medicines Agency (EMA), based on sound scientific principles,” said Xu. He added that the price has not yet been agreed.

Commenting on the relevance of the new data, Dr Rosa Giuliani, Consultant Medical Oncologist, Clatterbridge Cancer Centre, Liverpool, UK, said: “The development of biosimilars is important both for patients, by improving access to cancer drugs, and for health systems, allowing cost savings that can be re-invested in patient care and support the sustainability of healthcare systems.”

She noted that other trastuzumab biosimilars have been approved in Europe so the potential approval of China-produced HLX02 would add a further option.

"It is not acceptable that medicines which have shown to have a major impact on patients’ survival are not given in many parts of the world. Biosimilars are safe and effective drugs which can finally allow those patients to receive an appropriate standard of care," added Dr Giuliani.