What’s Next? Five Things To Look Out For In September
Alvotech Likely To Hear From USFDA On Humira Biosimilar
In the month ahead, Alvogen’s biosimilars sister company Alvotech is anticipated to receive a USFDA decision on its biosimilar Humira candidate, while Hikma’s management will meet investors to discuss prospects for its Generics business.
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Hikma told Generics Bulletin earlier this year it was reevaluating the US biosimilars market after witnessing successful launches from several of its rivals. Now the London-based firm has signed an agreement in the US to license and commercialize Bio-Thera Solutions’ Stelara biosimilar candidate.
While its COVID-19 vaccine, partnered with US-based Vaxxinity, is set to move to Phase III trials, Aurobindo has acquired an animal health company as well as several ANDAs and OTC assets. The acquisition and a deceleration in US sales caught analysts by surprise.
Alvotech underlined that it could “save US consumers and taxpayers billions annually,” after hitting a key landmark in its Phase III switching study for its high concentration 100mg/ml biosimilar Humira product.