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.
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.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.