Sandoz Sends Trastuzumab Biosimilar Application to FDA

On December 20, Sandoz announced the filing of its 351(k) application for a new Herceptin® biosimilar. If approved in 2022, it will be the sixth trastuzumab biosimilar competing on the market.

Sandoz already markets biosimilar versions of filgrastim (Zarxio®) and pegfilgrastim (Ziextenzo®), and it has received approval for etanercept (Erelzi®, which is not yet marketed in the US). If approved, EG12014 will be the first Sandoz biosimilar in which it is responsible only for commercializing the product . In 2019, the Basel-headquartered company signed an agreement with EirGenix, which developed the biosimilar compound and will be responsible for manufacturing and maintaining supply. This would be EirGenix’s first therapeutic drug to attain approval. It currently markets a COVID-19 antigen rapid test. EirGenix is based in Zhubei City, Taiwan.

The investigational biosimilar (EG12014) underwent Phase 3 testing in a study comprising up to 800 participants from multiple countries, including the US. This trial compared EG12014 against the reference product in patients with HER2-positive early-stage breast cancer (in combination with anthracycline and paclitaxel therapy).

Based on this submission date, the FDA may be expected to issue its decision in late Q4 of 2022. The trastuzumab field may become even more crowded in the near future. Tanvex Biopharma filed for its own biosimilar approval in early October of this year, and Prestige Biopharma is also seeking to advance its own biosimilar candidate in 2022. A full year ahead of the adalimumab launches, this may be the first test of market viability for such a large field of competitors in the US.  

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