Before the month is out, Alvotech hopes to hear back from the US FDA for its AVT02 high-concentration 100mg/ml biosimilar adalimumab candidate. The Icelandic firm, which remains embroiled in litigation with originator AbbVie, has reported top-line results from its key switching study. 

Alvotech and Natco have failed to persuade a US court that certain of AbbVie’s IP shielding its Imbruvica blockbuster is invalid. In response, the originator said that it did not anticipate generic competition to its branded oral therapy for treating forms of cancer until March 2032, assuming pediatric exclusivity is granted.

Just months ahead of the patent expiry for Votrient in India, Novartis hauls alleged infringer MSN Laboratories to court, which has bound the Indian firm by its pre-launch assurance for the anticancer therapy.

With “many pipeline products coming to the market in the next two years,” Alvogen’s US operation has raised fresh capital via a share issue to Aztiq Pharma, the private equity fund led by Alvogen CEO Robert Wessman.