18 Nov 2020 | All | Samsung Bioepis, Biogen | Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

12 Nov 2020 | All | Samsung Bioepis | Samsung Bioepis announces one-year results from Ph III study of SB...

Significant biosimilar activities this week include:

  • 31 Aug 20, US: Mylan and Biocon announced the launch of Semglee® (insulin glargine) in vial and pre-filled pen presentations in the US.   Semglee® is indicated for the treatment of adult and pediatric patients wit...

Significant biosimilar activities this week include:

  • June 08: the Centre for Biosimilars reported that the WHO certified Celltrion's Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims...

Significant biosimilar activities this week include:

  • 01 May 2020: AbbVie released its Q1 2020 financial results, reporting a 13.7% increase in US sales of Humira® from Q1 2019. In global markets, Humira® sales were down 14.9%, a decline that was attributed to biosim...

Significant biosimilar activities this week include:

  • On 21 April 2020, the Centre for Biosimilars reported that Xbrane Pharma was continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

    ...
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Biosimilars bulletin 

November 9, 2020

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