AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

SB3, also referred to as AMT901, is approved in the United States and the European Union under the name Ontruzant. The newly announced phase 3 study is expected to begin in the first quarter of 2020.

Approval of the application was based on a review of a comprehensive data package that included results from a clinical comparative study that found no clinically meaningful differences, in terms of efficacy and safety, between the biosimilar and the reference product in patients who have HER2-positive breast cancer.

“This CTA approval is an important milestone for AffaMed as we transition to a clinical-stage biotechnological company,” said Nathan Pang, MBBS, EMBA, chief executive officer of AffaMed, in a statement. “We are fully geared up to initiate this clinical development program, with the goal of providing AMT901 to help more Chinese patients at an affordable price.”

This new development comes after Samsung Bioepis reached a February 2019 agreement with private equity firm C-Bridge Capital to allow the drug maker to expand its reach into mainland China. Under the terms of the agreement, C-Bridge established AffaMed as a new company designed to collaborate with Samsung Bioepis on clinical development, regulatory activities, and commercialization of biosimilar products in China. In return, Samsung Bioepis will receive an upfront payment and royalties on sales.

In February, the parties announced that the agreement would cover multiple biosimilar candidates in Samsung Bioepis’ pipeline, including a ranibizumab biosimilar referencing Lucentis. The companies are also developing an aflibercept biosimilar, referencing Eylea.