THE INVESTOR

메뉴열기
March 19, 2024

[EXCLUSIVE] MacroGenics plans to launch Herceptin biobetter by 2021

PUBLISHED : June 27, 2017 - 16:53

UPDATED : June 29, 2017 - 17:36

  • 본문폰트 작게
  • 본문폰트 크게
  • 페이스북
  • sms

[THE INVESTOR] MacroGenics indicated on June 27 it has pushed back the launch of its biobetter version of Roche’s breast cancer treatment Herceptin to 2021 due to delays in clinical trials.

Margetuximab, an anti-HER2 antibody drug candidate developed by MacroGenics and Green Cross which is undergoing phase 3 clinical trials, was originally planned to hit the US market in 2016 when the company forged a license agreement with the US-based biotech firm in 2010. 





Unlike biosimilars, which are basically generic versions of branded drugs, margetuximab has the potential to be a best-in-class antibody which takes more time to develop, according to industry experts. True to their name, biobetters are new and improved versions of approved biological drugs.

“We anticipate completion of enrollment of the phase 3 trials in late 2018, with progression-free survival data reading out in 2019,” James Karrels, MacroGenics senior vice president told the Investor via email.

According to MacroGenics’ website, which holds a worldwide license to sell margetuximab except in Korea, the drug candidate is currently undergoing phase 3 clinical study to treat patients with breast cancer and phase 2 trials in advanced gastric cancer.

The decision to postpone the launch comes as Roche faces looming competition from biosimilars from companies like Celltrion and Samsung Bioepis that are poised to unveil their cheaper, near replica versions of Herceptin, which generated US$6.8 billion revenue in 2016.

“We don’t believe they (Herceptin biosimilars) are highly relevant to our development of margetuximab, given that our product candidate is being tested directly with Herceptin to determine superiority for progression-free survival and overall survival,” Karrels said.

Although margetuximab may target the same receptor as Herceptin and presumably its biosimilars, the company has optimized the fragment crystallizable region of our antibody to generate “greater cancer cell killing” through increased antibody-dependent cellular cytotoxicity, he added.

MGAH22 targets the human epidermal growth factor receptor 2, or HER2, oncoprotein, which is overexpressed on the surface of various cancer cells and plays an important role in tumorigenesis, tumor aggressiveness, and outcome in breast and other cancers. HER2 has proven to be an excellent target for cancer therapeutics as shown by the clinical success of trastuzumab in both breast and gastric cancer, according to the company.

By Park Han-na (hnpark@heraldcorp.com)

  • 페이스북
  • sms
최상단으로
COPYRIGHT HERALD CORPORATION. ALL RIGHTS RESERVED.