New biosimilar for Roche’s Avastin TGA registered

Pharma News: Amgen Australia secured the Therapeutic Goods Administration (TGA) approval of MVASI (bevacizumab-awwb), a biosimilar to Roche’s Avastin (bevacizumab).

Pfizer listed its Avastin biosimilar Zirabev on the ARTG in November 2019 and is awaiting the July 2020 PBAC meeting outcomes for a potential listing.

Amgen’s MVASI is approved for the treatment of five types of cancer:

• in combination with chemotherapy for metastatic colorectal cancer (mCRC)
• in combination with chemotherapy for non-squamous non-small cell lung cancer (NSCLC)
• locally recurrent or metastatic breast cancer
• recurrent glioblastoma
• in combination with interferon alfa-2a for metastatic renal cell carcinoma
• epithelial ovarian, fallopian tube or primary peritoneal cancer
• in combination with chemotherapy for persistent, recurrent, or metastatic cervical cancer.

In December 2011, Amgen and Allergan formed a collaboration to develop and commercialise, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialisation of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercialising the oncology antibody products.

MVASI and KANJINTI were proven to be highly similar to, and to have no clinically meaningful differences in terms of safety and effectiveness from Roche’s Avastin and Herceptin, respectively, based on a totality of evidence, which included comparative analytical, clinical safety and efficacy data.