Alvotech Moves Forward As Aflibercept Filing Lands On EMA’s Desk

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.