Prestige Biopharma is drawing attention from market watchers after announcing that its biosimilar HD201 has demonstrated equivalence in efficacy and safety profiles compared with the reference product Herceptin.
Prestige Biopharma said Thursday that it reported the final results of its phase 3 clinical trial on its Herceptin biosimilar HD201 to the drug regulators.
“Through the phase 3 trial results, the company has proven the biosimilarity in terms of efficacy, safety, and pharmacokinetics between HD201 and the original drug Herceptin,” the company said.
Prestige Biopharma has been conducting a global phase 3 trial for HD201 on 502 patients with HER2-positive early (stage 2-3) breast cancer, participated by 70 medical institutions in 12 countries, including France, Spain, Italy, Poland, Estonia, Bulgaria, Georgia, Belarus, Ukraine, Malaysia, Thailand, and Russia from 2018.
The company divided the patients into two groups. First, it administered HD201 or Herceptin surgery as a combination therapy with docetaxel, epirubicin, and cyclophosphamide eight times before surgery and 10 times as monotherapy after surgery.
Afterward, the company compared and analyzed the total pathological complete remission (tpCR), breast pathological complete remission (bpCR), and overall response rate (ORR), which means that the breast and axillary lymph node tumors have completely disappeared between the two groups through biopsy at the time of surgery, and the overall survival (OS) and event-free survival (EFS) of the HD201-administered group and the Herceptin-administered group through follow-up for an additional two years after the end of the one-year clinical treatment period.
According to the company, tpCR, the primary endpoint, data showed a difference of -3.8 percent between the HD201-administered group and the Herceptin-administered group, satisfying the pre-established biosimilarity range.
As for bpCR, the secondary endpoint, the difference between the HD201-administered and the Herceptin-administered groups was -0.9 percent, confirming biosimilarity, and the ORR index of the HD201-administered group and the Herceptin-administered group were 91.2 and 89.0 percent, respectively, confirming equivalence between the two drugs.
OS and EFS were analyzed over three years of the clinical treatment period of one year, and a follow-up period of two years was 95.6 and 85.6 percent in the HD201-treated group and 96 and 84.9 percent in the Herceptin-administered group, again confirming equivalence between the two drugs.
The company had previously applied for product approval to the European Medicines Agency (EMA) in 2019 based on the evidence of equivalence secured during a one-year clinical treatment period.
“Currently, the EMA, Health Canada, and the Ministry of Food and Drug Safety are reviewing the company’s product approval application,” the company said. “After EMA approval, the company plans to advance into the European market.”
The company also explained that it is in the process of advancing into the U.S. market.
“HD201 is currently preparing to apply for U.S. Food and Drug Administration (FDA) product approval, and the company is faithfully preparing for product approval requirements,” a company official said. “Through the results of the FDA bridging clinical trial conducted in 2020, the company has confirmed excellent equivalence with the original drug.”
In July last year, the company published the Pharmacology Research & Perspective results, she added.
Meanwhile, the stock price of Prestige Biopharma soared and reached the upper limit after the company announced its phase 3 trial results. The stock price of Prestige Biopharma, which was 14,100 won ($11.56) as of the closing price on Thursday, rose 4,200 won (29.79 percent) to close at 18,300 won on Friday.