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Perrigo Rolls Out US ProAir Rival

Launches ‘Limited Quantity’ After FDA Nod And Ramps Up Production

 
• By Dave Wallace

Perrigo has received US FDA approval for a generic version of Teva’s ProAir albuterol inhaler. The firm is immediately launching a “limited quantity” but is also ramping up production with partner Catalent to meet future demand.

Inhaler
Perrigo is already rolling out its rival to Teva’s ProAir • Source: Shutterstock

Perrigo has received the first US Food and Drug Administration approval for a generic rival to Teva’s ProAir HFA (albuterol sulfate) inhaler. The firm is launching a “limited quantity” of its generic version immediately, while working with its development and manufacturing partner Catalent Pharma Solutions to ramp up production to meet future demand, which it expects to be able to serve by the fourth quarter of this year.

Annual gross sales of ProAir HFA were around $1.4bn, Perrigo said, citing IQVIA data

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Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By Dean Rudge

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.

Adalvo And Gedeon Richter Join Forces On Semaglutide

 
• By Dave Wallace

Adalvo and Gedeon Richter have announced a global co-development deal for semaglutide for obesity. Adalvo CEO Anil Okay spoke to Generics Bulletin about the alliance as well as the broader competitive landscape for GLP-1s.

Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

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Tofidence And Tariffs - Organon Discusses Exposure Of Its Biosimilars Business

 
• By Dave Wallace

During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.

Lupin Touts FDA Approval For Generic Tolvaptan With 180-Day Exclusivity

 
• By Urtė Fultinavičiūtė

After receiving a favorable court ruling last year, Lupin has secured its first-place spot for generic tolvaptan tablets in the US.

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.