US FDA rejects another Herceptin biosimilar, Amgen issued CRL

By Flora Southey contact

- Last updated on GMT

(Image: Getty/Bet_Noire)
(Image: Getty/Bet_Noire)
The US FDA has issued a complete response letter to Amgen for its biosimilar version of Roche’s Herceptin, marking the agency’s third trastuzumab candidate rejection this year.

The US Food and Drug Administration (FDA) has vetoed Amgen’s biologics license application (BLA) for ABP 980 – a biosimilar version of Roche’s best-selling monoclonal antibody (mAb) Herceptin (trastuzumab).

ABP 980 – co-developed by Amgen and Allergan – was submitted for US regulatory review in July last year​. The candidate is designed to treat HER2-overexpressing early breast cancer, adjuvant breast cancer, metastatic breast cancer, and metastatic gastric cancer. 

The firm did not disclose details of the complete response letter (CRL) but said it is determined to proceed with the market authorisation process.

“We will work closely with the FDA to bring this important medicine to patients in the US,” ​a spokesperson told us. “We do not expect this to impact our US launch plan.”

The CRL marks the FDA’s third rejection of a Herceptin biosimilar candidate this year. 

In April 2018​, Korean drugmaker Celltrion announced receipt of an FDA CRL for CT-P6 (trastuzumab) and later the same month​ the FDA rejected Pfizer’s Herceptin biosimilar candidate, PF-05280014.

The FDA has approved just one Herceptin biosimilar to date: Mylan and Biocon’s Ogivri (trastuzumab-dkst) in December 2017​.

Related topics: Markets & Regulations, Biosimilars

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