Alvotech’s Drug Approved In Europe As Biosimilar For Bone Disease Drug

• The company said that AVT03 is approved as a biosimilar to Prolia 60 mg/mL single-use pre-filled syringe and as a biosimilar to Xgeva 70 mg/mL single-use vial.
• STADA will market AVT03 as Kefdensis and Zvogra, while Dr. Reddy’s will market AVT03 as Acvybra and as Xbonzy. 
• The EC approval is based on clinical studies that demonstrated equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product, the company said.

Alvotech (ALVO) on Monday said that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s Prolia and Xgeva, containing the active ingredient denosumab, and used widely to manage osteoporosis.

According to Alvotech, the European denosumab market is currently valued at approximately $1.2 billion across all indications. While widely used to manage osteoporosis, it is also used to prevent skeletal-related events in patients with certain cancers. Osteoporosis is a disease in which your bones become weak and are more prone to fracture due to a decrease in bone mineral density and bone mass.

EC Approval

The company said that AVT03 is approved as a biosimilar to Prolia 60 mg/mL single-use pre-filled syringe for the treatment of osteoporosis and bone loss, and as a biosimilar to Xgeva 70 mg/mL single-use vial for the prevention of skeletal-related events in adults with advanced malignancies involving bone.

AVT03 will be commercialised in Europe in partnerships with STADA Arzneimittel AG and Dr. Reddy’s, the company said.  STADA will market AVT03 as Kefdensis and Zvogra, while Dr. Reddy’s will market AVT03 as Acvybra and as Xbonzy.

The EC approval is based on clinical studies that demonstrated equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product, the company said.

How Did Stocktwits Users React?

Shares of the company traded flat in the pre-market session at the time of writing. On Stocktwits, retail sentiment around ALVO jumped from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.

ALVO stock is down 61% this year and by 57% over the past 12 months. 

Also See: Novo Nordisk’s Blockbuster Drug Fails To Slow Alzheimer’s Disease Progression In Studies

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