China’s Tot Biopharm Secures First Antibody Approval With Avastin Biosimilar

Regulator NMPA Approves Pusintin Biosimilar Product For Cancer Indications

After listing on the Hong Kong stock exchange in late 2019, China’s Tot Biopharm has delivered its first antibody drug approval, with its Pusintin (bevacizumab) biosimilar to Avastin.

China - Suzhou City
Tot has manufacturing in the Suzhou Industrial Park • Source: Shutterstock

Chinese oncology specialist TOT BIOPHARM has received approval from the country’s National Medical Products Administration for its Pusintin (bevacizumab) biosimilar to Avastin, “the first antibody drug of Tot Biopharm approved for marketing.”

Approved to treat advanced, metastatic, or recurrent non-squamous non-small cell lung cancer and metastatic colorectal cancer, the Pusintin biosimilar was waved through by the NMPA after Tot Biopharm “strictly followed” the agency’s

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By 

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 

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 

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.

More from Products

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By 

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By 

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 

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.