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Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the…

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PTAB Issues Final Written Decisions Finding Most Claims of Sanofi’s Lantus Patents Invalid

As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection).  On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…

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Revance Therapeutics, Mylan, and Formycon Announce Updates to Their Biosimilar Plans

Revance Therapeutics, Mylan, and Formycon have announced updates to their biosimilar plans.  In the Q1 2020 Earnings Conference Call on May 7, 2020, Revance updated investors on the biosimilar to BOTOX® program in potential partnership with Mylan.  Revance informed investors that Mylan had requested additional information from Revance, and would…

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Study Says that Conversion of Intermediate-Risk FN Patients to Pegfilgrastim Biosimilar Likely to Have Large Budget Impact

A new study funded by Sandoz related to the budget impact of expanding patient access to biosimilar pegfilgrastim (Ziextenzo) was presented during the Academy of Managed Care Pharmacy’s AMCP eLearning Days virtual meeting in April. The study found that expanding access to Ziextenzo to patients with intermediate risk of developing febrile…

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Biosimilar Buyouts: AbbVie Buyout of Allergan Receives Approval of Irish High Court; Gedeon Richter Buys Tocilizumab Biosimilar

On May 8, 2020, AbbVie announced that it completed its acquisition of Allergan plc, having received approval by the Irish High Court.  AbbVie and Allergan had previously announced, on May 5, 2020, that the U.S. Federal Trade Commission accepted the proposed consent order in connection with the acquisition.  As part of…

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AryoGen’s bevacizumab biosimilar BE1040V found noninferior to AVASTIN in phase III study

In a study published in Clinical Therapeutics on April 22, AryoGen Pharmed’s proposed bevacizumab biosimilar, BE1040V (STIVANT), was found to be noninferior to the reference product (AVASTIN) in a Phase III clinical trial in patients with metastatic colorectal cancer.  AryoGen Pharmed is a pharmaceutical manufacturer based in Iran that specializes…

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