Prestige’s HD201, a Biosimilar to Herceptin, Accepted for Review in Europe for HER2-positive BC

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) submitted by Prestige BioPharma for HD201, its lead biosimilar to Genentech‘s Herceptin (trastuzumab).

Like Herceptin, HD201 is indicated for the treatment of women with HER2-positive breast cancer. Prestige’s lead biosimilar candidate also is indicated for treating patients with HER2-overexpressing advanced metastatic gastric or gastroesophageal junction adenocarcinoma.

A biosimilar is a nearly identical, yet lower-priced version, of an original brand medication. Pharmaceutical companies may start producing biosimilars when the patent of the original brand product expires, after obtaining a license from its manufacturer.

According to top-line data from two ongoing clinical trials — the Phase 1 TROIKA-1 trial (NCT03776240) and the Phase 3 TROIKA trial (NCT03013504) — the efficacy, safety, and tolerability profiles of HD201 are highly similar to those reported for Herceptin when administered to healthy volunteers and patients with early HER2-positive breast cancer. HD201’s stability and overall metabolism in the body also are highly similar to that reported for Herceptin.

This is Prestige BioPharma‘s first biosimilar candidate therapy that has received a positive feedback from EMA’s Committee for Medicinal Products for Human Use (CHMP), which recommended the approval of HD201’s marketing application.

Based on this positive experience, the company is now planning to go ahead with the development and clinical testing of eight other biosimilar candidates in its research pipeline. These include HD204, a biosimilar to Genentech’s Avastin (bevacizumab), indicated for solid tumors, and PBP1502, a biosimilar to AbbVie‘s Humira (adalimumab) for treating arthritis.

“We are very pleased that EMA has initiated the review of the HD201 Marketing Authorisation Application,” Lisa S. Park, CEO of Prestige, said in a press release. “It is a major step in our endeavor to become a global player focusing on biosimilars and innovative biologics.”

“Our development approach has proven to be highly efficient with regard to trial performance, demonstrating exceptional similarity, and dossier filing,” she said.

If successful, HD201 may join other Herceptin biosimilars, including Celltrion‘s Herzuma, Amgen‘s Kanjinti, Merck Sharp & Dohme‘s Ontruzant, and Pfizer‘s Trazimera, in the E.U. healthcare market. These biosimilars compete with Herceptin, which is still the market leader.