After a number of development challenges and setbacks, Hikma has now received US Food and Drug Administration approval for and launched its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) in the US.
Hikma Launches Long-Awaited US Advair Rival
Competes With Viatris’ Wixela Inhub, But Not In All Strengths
Hikma has gained FDA approval for and launched its long-in-development generic version of Advair Diskus. The milestone puts it in direct competition with Viatris’ Wixela Inhub version that was launched almost two years ago, in three presentations compared to Hikma’s two.
More from Products
• By
Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.
• By
The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?
• By
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
• By
Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
More from Generics Bulletin
• By
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
• By
Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
• By
Generics Bulletin previews the most noteworthy and anticipated events for April 2025.