1. Generics Bulletin
  2. >>Products

Bio-Thera Secures FDA Approval For Sandoz-Partnered Bevacizumab Biosimilar

Avzivi Is The Second Bio-Thera Biosimilar – And The Second Chinese Biosimilar – To Secure FDA Approval

 
• By Chloe Kent

Bio-Thera has received US Food and Drug Administration approval for its bevacizumab biosimilar, marking the second biosimilar drug researched, developed and manufactured by a Chinese pharmaceutical company to receive US approval.

Hands emblazoned with US and China flags about to shake
Bio-Thera has developed both biosimilars researched, developed and manufactured by a Chinese company to recieve US FDA approval • Source: Shutterstock

Chinese biosimilar developer Bio-Thera Solutions Ltd. has received approval from the US Food and Drug Administration for its Avastin (bevacizumab) biosimilar Avzivi (bevacizumab-tnjn). The drug has already been approved in China since November 2021, as well as in other Asian countries.

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
Start Free Trial

Already a subscriber?

More from Products

Biocon Chooses To Settle Over Eylea In US – Will Others Follow?

 
• By Dave Wallace

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

As US Launches Pharma Probe, AAM Warns Tariffs ‘Will Only Amplify Problems’

 
• By Dave Wallace

News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.

Sandoz Attacks Amgen Over US Enbrel Exclusivity

 
• By Dave Wallace

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

More from Generics Bulletin

Cipla Welcomes Abraxane ANDA Approval After Tackling Goa Compliance Issues

 
• By Dean Rudge

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

Biocon Celebrates Long-Awaited FDA Approval For Bevacizumab Biosimilar

 
• By Urtė Fultinavičiūtė

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

Emcure’s Subsidiary Tillomed Boosts Portfolio With $20m+ Manx Deal

 
• By Adam Zamecnik

The company did not disclose which particular drugs it secured through the deal that further boosted its portfolio that already includes more than 100 assets.