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Hikma Resumes Launch Of Advair Rival

Follows FDA Approval Of ANDA Amendment That Forced Pause

 
• By Dave Wallace

Hikma has restarted launch activities for its generic version of GSK’s Advair respiratory blockbuster in the US, after the FDA gave the go-ahead following approval of an ANDA amendment.

Restart Wooden Blocks
Hikma has restarted launch activities for its generic version of Advair • Source: Alamy

Hikma “will immediately resume launch activities” for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) in the US, after the Food and Drug Administration approved a necessary amendment to the firm’s abbreviated new drug application that had forced it to put launch plans on hold in early 2021.

The firm’s generic rival to Advair was approved by the FDA late last year in 100mcg/50mcg and 250mcg/50mcg presentations and was in the process of being introduced to the market at the tail end of 2020, only for the launch to be halted by the FDA requesting an amendment to the ANDA to reflect “enhanced packaging controls to meet new industry standards adopted since the initial submission

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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.