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What’s Next? Five Things To Look Out For In September

Alvotech Likely To Hear From USFDA On Humira Biosimilar

 
• By Dean Rudge

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.

Whats_Next_2020_2
A key Jevtana patent will expire this month • Source: Informa

Alvotech’s high-concentration biosimilar version of Humira (adalimumab), the company’s AVT02 candidate, is anticipated to receive its US Food and Drug Administration decision during September, following its filing with the agency a little under a year ago. (Also see "Alvotech Files Higher-Strength Adalimumab In US And EU" - Generics Bulletin, 19 November, 2020.)

The Alvogen sister company’s AVT02 higher-strength version of adalimumab had produced positive Phase I and Phase III data earlier in...

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Hikma Rides Price Gap as Novo’s Ozempic, Wegovy Costs Climb

 
• By Dean Rudge

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 
• By Urtė Fultinavičiūtė

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Arizonans To Be Offered Up To 80% Discount On Generic Drugs

 
• By Urtė Fultinavičiūtė

Arizona’s governor Katie Hobbs pointed to Trump’s One Big Beautiful Bill and other federal failures as she signed an executive order to increase access to medications in her state.