Alvotech Champions Switching Data As Clock Ticks On Adalimumab Filing
Top-Line Results Announced In Major Switching Study; Bioequivalence Demonstrated
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.
You may also be interested in...
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.
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.
Teva is keeping a keen eye out for opportunities like its US biosimilars agreement with Alvotech and more recent deal with Bioeq for biosimilar Lucentis as it attempts to maintain revenues in the coming years, following a cut to full-year sales guidance for 2021.