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Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'

 
• By Anju Ghangurde

Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.

Investors Await Clarity On Generic Advair Launch Timeline • Source: Shutterstock

Launch timelines for Cipla’s long-awaited generic (g) Advair (salmeterol/fluticasone) in the US now hinge on whether its Indore site in India makes the compliance cut, but the firm claimed that even if things don’t go its way, the value proposition for the product remains unaltered.

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Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

 
• By Urtė Fultinavičiūtė

Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.

Teva Crib Sheet Reveals Uzedy, Lenalidomide Expectations Ahead Of Q1

 
• By Dean Rudge

Teva is charting a new course under its ‘Pivot to Growth’ strategy, providing a memory aid for investors to better understand the firm’s financials going into 2025.

Alvotech Reveals Ramp-Up In Development As Sales Explode In 2024

 
• By Dave Wallace

With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.

Henlius Builds Profitability Streak With Second Year In The Black

 
• By Adam Zamecnik

The Chinese player reported its second profitable year in a row, with growth in sales reported across its marketed portfolio and further milestones in the near future.

More from Business

Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

 
• By Urtė Fultinavičiūtė

Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.

Celltrion Unveils Strategy Amid Series Of Milestones

 
• By Adam Zamecnik

South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.

Samsung Rolls Out Second US Soliris Biosimilar – At 30% WAC Discount

 
• By Dean Rudge

Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.