November 23, 2020

Significant biosimilar activities this week include:

  • 15 Nov 20, US: Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin in the Eastern District of Texas, relating to 10 Genentech licen...

  • 16 Nov 20 | CSL | CSL's Sequiris announced it will build a next-generation $800 million influenza vaccine manufacturing facility in Australia. The facility is expected to be operational by mid-2026 and will be the only cell-based influenza vaccine manuf...

November 16, 2020

Significant biosimilar activities this week include:

  • 05 Nov 20: Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, whi...

Significant biosimilar activities this week include:

  • 05 Nov 20: Teva released its Q3 2020 financial results, reporting a 2% increase in generic and biosimilar revenues in North America compared to Q3 2019. Teva attributed this increase in part to higher...

Significant biosimilar activities this week include:

  • 22 Oct 20: Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commenced recruiting in Poland
     

  • 26 Oct 20: Samsung Bioepis announced results from...

Significant biosimilar activities this week include:

  • 15 Oct 20: Henlius and Essex announced they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an...

Next year, the UK will conclude its transition  from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK's Medicines and Healthcare products Regulatory Agency (MHRA).  This new regime will apply from 01 January 202...

Significant biosimilar activities this week include:

  • 09 Oct 20, CN: Innovent and Eli Lilly jointly announced China's NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffu...

Significant biosimilar activities this week include:

  • 05 Oct 20: Medicure announced it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsib...

Significant biosimilar activities this week include:

  • 28 Sep 20: Innovent announced its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall s...

September 30, 2020

The TGA has approved GW Pharma's Epidyolex® (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients over 2 years of age.  

Epidyolex® was developed by GW Pharma in partnership...

September 28, 2020

Significant biosimilar activities this week include:

  • 21 Sep 20, EU: Alexion announced it has received a positive opinion from the EU's CHMP for a new 100mg/mL formulation of Ultomiris® (ravulizumab).  The new formulation requires an infusion time of 0.4...

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November 9, 2020

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