Boan Biotech Begins International Phase III Trial Of Denosumab Biosimilars

One Product Is Already Approved For Marketing In China

Having already launched one of its denosumab biosimilar products in China, Boan Biotech has now commenced an international Phase III study to secure approval in Europe, the US and Japan.

US, EU and Japanese flags
The international study has been initiated in Europe, the US and Japan • Source: Shutterstock

Following the approval of its Prolia (denosumab) biosimilar in China late last year, Luye Pharma Group, Ltd. subsidiary Boan Biotech has now enrolled the first subject in an international multi-center Phase III clinical study for its two denosumab candidates, BA6101 and BA1102.

More from Products

Teva Shares Encouraging Patient Survey Data For Long-Acting Olanzapine

 
• By 

Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
• By 

Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

More from Generics Bulletin

Organon Looks To Tap Tocilizumab Potential Following Biogen Acquisition

 
• By 

Organon has swelled its immunology biosimilar portfolio after acquiring the US commercial rights to Bio-Thera’s tocilizumab biosimilar from Biogen, which last year decided to retain its interests in biosimilars following a lengthy strategic review.

Another One Bites The Dust: FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 

The US FDA has deemed certain CRO Raptim Research’s in vitro bioequivalence studies as “not acceptable” and raised concerns over its in vivo study methods. Will other agencies follow suit?

EMA Validates Henlius’ Pertuzumab Biosimilar Application

 
• By 

The EMA has accepted for review Henlius’ Perjeta biosimilar, which is to be commercialized by the Chinese company’s global partner Organon in the EU.