December 1, 2020

In Pfizer Ireland Pharmaceuticals v Sandoz Pty Ltd [2020] FCA 1648, the Federal Court of Australia declined to order preliminary discovery against Sandoz, the holder of an ARTG registration for biosimilar etanercept, that had no present intention to launch its ERELZI®...

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 two post-mar...

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 survival.  In...

Significant biosimilar activities this week include:

  • 14 Sep 20: Novartis announced the results of Ph III trials of Beovu® (brolucizumab) in diabetic macular edema. Novartis announced the trial met its primary and key secondary endpoints, demonstrating non-inferiorit...

Significant biosimilar activities this week include:

  • 24 Aug 20, JP: Merck announced Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

    • new indication for the treatment of patient...

Significant biosimilar activities this week include:

  • 27 Jul 20, EU: Celltrion announced the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spon...

Significant biosimilar activities this week include:
 

  • June 28 US: Genentech filed a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung's proposed bevacizumab biosimil...

Significant biosimilar activities this week include:

  • May 29: in a filing to the Securities and Exchange Commission, Alexion announced it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to m...

Significant biosimilar activities this week include:

  • 11 May: AstraZeneca announced it had recovered the global rights to brazikumab from Amgen. AstraZeneca had previously collaborated with Amgen to jointly develop and commercialise the product. Brazikumab is a monoc...

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November 9, 2020

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