Mylan's Bevacizumab Biosimilar Gains Decision Date

Mylan has reported in a recent earnings call that the FDA has accepted its 351(k) filing application for the bevacizumab biosimilar MYL-1402O. The FDA granted the application for the biosimilar to Avastin a decision date of December 27, 2020.

The pharmaceutical company, which is developing the drug with Biocon, said a European marketing approval application for the same drug has been filed.

Bioequivalence to the US and European Union versions of reference drug Avastin was demonstrated for MYL-14020 in a phase 1 study (n = 111) of men with metastatic colorectal cancer. Treatment emergent adverse events were also consistent with the clinical data for Avastin, indicating comparable tolerability and no significant safety issues.

There are currently 2 bevacizumab biosimilars on the market, with another potential biosimilar, Samsung Bioepis’ SB 8, still under review. The FDA accepted SB 8 for review in November 2019. If approved, SB 8 would be marketed by Merck.

In the same conference call, Mylan officials provided an update on their plans to bring a Botox (onabotulinumtoxinA) biosimilar to market. The company said it is currently working closely with the FDA to evaluate data to ensure it has a “viable product.” If all goes well, the biosimilar could be launched before 2025.

Mylan has previously indicated it hopes to be the first to market with a biosimilar for Botox, a neuromuscular blocking agent used in the treatment of incontinence, migraines, upper limb spasticity, cervical dystonia, and strabismus, and cosmetic changes.

The company also indicated that a proposed biosimilar to Eylea (aflibercept) injection is on track for an FDA submission in early 2021. The drug is being developed by Mylan and Momenta Pharmaceuticals.

Eylea is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in patients with diabetic macular edema.

In December 2019, Mylan and Biocon announced that their biosimilar trastuzumab, Ogivri, has become commercially available in the United States. The biosimilar, referencing Herceptin, is now available in a 420-mg multidose vial and a 150-mg single-dose vial.