FDA Reviews Samsung Bioepis’ Bevacizumab

Avastin Rival Will Be Sold Through Merck, Sharp & Dohme

Samsung Bioepis has announced that its SB8 biosimilar bevacizumab candidate, a proposed US rival to Avastin, has been accepted for review by the FDA.

Accepted_Stamp
Samsung Bioepis’ Bevacizumab Filing Has Been Accepted By The FDA • Source: Shutterstock

Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, has announced that its filing for a US biosimilar rival to Genentech’s Avastin (bevacizumab) has been accepted for review by the US Food and Drug Administration.

More from Biosimilars

More Insights Revealed At J.P. Morgan Conference

In the aftermath of last week’s J.P. Morgan Healthcare Conference in San Francisco, Generics Bulletin’s editorial team brings you additional coverage of items of interest for the global generics and biosimilars industry.

Henlius Builds On Abbott Biosimilar Partnership Gaining 69 Emerging Markets

 

Henlius casts a wider net for its biosimilars presence by locking in a fresh deal with the already-established partner Abbott. Also, the Chinese biosimilars developer has joined the Biosimilars Forum, securing its footing in the US.

Building A Sustainable Market: New Medicines For Europe President Sets Out Priorities

 
• By 

Recently-appointed president of Medicines for Europe Stephan Eder speaks to Generics Bulletin about the off-patent association’s priorities to secure a sustainable operating environment for the generics, biosimilars and value-added medicines sector in Europe.

Amneal Is Targeting 70% Of Untapped Biologics In The ‘Golden Era’ Of Biosimilars

 

While Amneal cannot wait to jump into unexplored biologics space, it wants to channel its GLP-1 power into the Metsera partnership and service big pharma, and less so on its own generics.

More from Products

Richter, Mochida To Move Ahead On European, Japanese Tocilizumab Filings

 
• By 

Hungary’s Gedeon Richter and its Japanese partner Mochida have together unveiled plans to file their proposed Actemra/RoActemra biosimilar with major regulators, after biosimilar competition to the IL-6 receptor inhibitor materialized in the US last year.

Amgen Reveals Ocrelizumab Biosimilar Ambitions

 
• By 

As Bob Bradway addressed the J.P. Morgan Healthcare Conference in San Francisco, the Amgen chief executive discussed the firm’s biosimilars business – including an ocrelizumab rival to Ocrevus that has just been added to its pipeline. Meanwhile, the CEO also outlined his expectations for imminent biosimilar competition to Amgen’s Prolia and Xgeva denosumab brands.