Mylan and Biocon's proposed bevacizumab biosimilar to get FDA review

UK-domiciled Mylan (Nasdaq: MYL) and India’s Biocon (BSE: 532523) said today that the US Food and Drug Administration has accepted the Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.

Other biosimilars of Roche’s (ROG: SIX) blockbuster cancer drug Avastin have already been approved in the USA including Pfizer’s (NYSE: PFE) Zirabev (bevacizumab-bvzr), which saw its debut in the American market in December 2019 at a Wholesale Acquisition Cost (WAC) of $61.34 per 10mg, representing a 23% discount to the WAC of Roche’s Avastin, which clocked up global sales of around $7 billion in 2019. Also approved is Mvasi (bevacizumab-awwb), from Amgen (Nasdaq: AMGN) and Allergan (NYSE: AGN), which has yet to launch in the USA.

The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.