Sandoz submits BLA for breast and gastric cancer targeted biosimilar drug

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Ildo Frazao
© GettyImages/Ildo Frazao

Related tags: Sandoz, Biosimilars, Breast cancer

Sandoz has submitted its Biologics License Application (BLA) for a proposed biosimilar trastuzumab developed by EirGenix, Inc to the US Food and Drug Administration (FDA).

Trastuzumab (150 mg, for intravenous use) is a monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers.

Sandoz is seeking approval for the same indications as the reference medicine, based, it said, on a comprehensive package that includes analytical, preclinical, and clinical data.

“Approximately 15-20% of all breast cancer patients have tumors that are HER2- positive and, as these tumors tend to grow more quickly than HER2-negative tumors, getting treated swiftly can be live-saving.

“Trastuzumab is standard of care so, if approved, we will introduce more competition aiming to broaden access to this important therapy and liberate healthcare resources that can be used to fund other innovative medicines in the US,”​ said Florian Bieber, global head of biopharmaceuticals development, Sandoz.

As part of the license agreement signed in April 2019, EirGenix is responsible for development and manufacturing and Sandoz will have the right to commercialize the medicine upon approval in all markets excluding China and Taiwan.

Strategic review of Sandoz business

The collaboration, said Sandoz, will enable it to build on its generic and biosimilar oncology portfolio to further expand patient access.

In October, Sandoz said it was planning to launch six biosimilar products across the US and EU in the next few years.

In the first nine months of 2021, the Novartis owned company saw its sales in the US decline 17%, as per financial results released in October.

Novartis also announced that month it was initiating a strategic review of the Sandoz division. All options are on the table, said the parent company, including holding on to the business or divesting it. An update on that review is expected at the end of 2022.

To date, the FDA has approved 31 biosimilars, including two interchangeable biosimilars, for the treatment of a variety of health conditions. 

 

Related topics: Markets & Regulations, Biosimilars

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