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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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TRUXIMA launches as first U.S. Rituxan® biosimilar approved for RA

Teva and Celltrion Healthcare announced today the U.S. launch of TRUXIMA® (rituximab-abbs) for rheumatoid arthritis (RA).  TRUXIMA®, which originally launched in November 2019, is now approved to treat RA, non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyaniitis (MPA) in adult patients. …

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FDA/FTC Joint Workshop on a Competitive Marketplace for Biosimilars – Comments from Stakeholders

As we have previously reported, in February 2020 FDA and FTC announced a joint collaboration “to advance competition in the biologic marketplace.” On March 9th, the two agencies held a public workshop to discuss their “collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading statements about biosimilars, and…

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