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Biocon Waits On FDA Insulin Inspection

Indian Company Seeks US Agency Stance On Mutual Recognition Agreement Route

 
• By Anju Ghangurde

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Firms Await Regulatory Inspections
Indian Firms Face Limited Visibility In Inspection Schedules • Source: Alamy

Front-line Indian companies like Biocon have a lot riding on regulatory inspections going through as scheduled amid pandemic-related travel restrictions to countries where plants are located.

The Bengaluru-based firm indicated that the US Food and Drug Administration had scheduled a pre-approval inspection of its manufacturing facility in Malaysia in the third quarter of calendar year 2021, in support of its biosimilar insulin aspart biologics license application, though investors appeared concerned

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Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By Dave Wallace

One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.

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.

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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