Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US. The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without … Continue reading Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success
Tag: Zarxio
Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
On July 20, the US Food and Drug Administration (FDA) approved the second biosimilar version of filgrastim. Pfizer's filgrastim biosimilar is named Nivestym™ (filgrastim-aafi). The originator product, Amgen’s Neupogen®, has steep competition from two other products (Sandoz’s Zarxio® [filgrastim-sndz] and Teva’s Granix® (tbo-filgrastim]). Granix was approved as a follow-on biologic, before the biosimilar pathway was … Continue reading Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used to encourage use of the originator product. In fact, … Continue reading Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
On October 27, Sandoz announced that the European Medicines Agency has accepted its re-application for review of its biosimilar version of Neulasta® as supportive treatment in patients receiving cytotoxic chemotherapy. Sandoz’s attempt to bring its biosimilar pegfilgrastim to the market was stalled in the US in Q2 2016, when the FDA issued a complete response … Continue reading Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
Evidence to Support Zarxio Use Presented at AMCP
Researchers studied the effect of a step edit, requiring the use of either Zarxio or Granix first, and its effect on utilization trends and cost savings among 2.7 million covered lives.
Rituximab and Filgrastim Biosimilars Being Reviewed by FDA
Sandoz's Rituximab and Adello Biologic' Filgrastim Biosimilars Submitted to FDA
Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?
In Europe, several manufacturers are marketing approved biosimilars to the same originator product. In fact, 7 manufacturers compete for the biosimilar filgrastim market, 5 biosimilar versions of epoetin are sold, and 3 biosimilars of infliximab seek marketshare from Remicade®. In the US, this situation is not a reality yet. It will be one day, however, and … Continue reading Are 2 Biosimilars to the Same Originator Product Biosimilar to Each Other?