Pearce IP BioBlast: w/e 15 May 2020

Significant biosimilar activities this week include:

  • 11 May 2020: Healio reported on a new study comparing faricimab to ranibizumab which was presented at a virtual meeting of the Association for Research in Vision and Ophthalmology. The presenters announced that faricimab showed sustained efficacy with a significantly lower frequency of administration as compared with ranibizumab.

     

  • 12 May 2020: Alvotech released the results of two studies for AVT02, a proposed adalimumab biosimilar, announcing both studies met their primary endpoints. Alvotech announced that the Ph I clinical study demonstrated the PK similarity of AVT02 to the reference product Humira®, while the Ph III study demonstrated equivalent efficacy compared to Humira® in patients with moderate-to-severe chronic plaque psoriasis.

     

  • 15 May 2020: Formycon released an update on its biosimilar portfolio. In the statement, Formycon confirmed it is continuing to work with license partner Bioeq on a resubmission of the BLA for FYB201 (proposed ranibizumab biosimilar). Additionally, Formycon's biosimilar aflibercept candidate is proceeding as expected, with Ph III clinical trials expected to begin mid-2020.  Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 2020. Formycon also announced that an undisclosed product, FYB206 is in the preclinical stage.

     

  • 15 May 2020: Samsung Bioepis announced the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.

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August 19, 2020

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