Tagged as: Pegfilgrastim

Coherus Neulasta biosimilar loses preferred status at Express Scripts

Last week it was announced that Coherus BioSciences’s pegfilgrastim biosimilar Udencya would be excluded from Express Scripts’s preferred formulary starting January 1, 2021. The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s Fulphila and Sandoz’s Ziextenzo.

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Global Biosimilars Approval and Launch Updates

Shanghai Henlius Biotech, Inc. announced on August 14, 2020 the approval of its trastuzumab biosimilar HLX02 by the National Medical Products Administration (NMPA).  This same product was approved by the European Commission on July 27th.  According to the press release, this is the the first China-developed mAb biosimilar to be…

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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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U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab).  According to the press release, “OGIVRI™ is approved for all indications of HERCEPTIN® including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma),” and is available in both…

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Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

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BREAKING NEWS: Federal Circuit Affirms Sandoz’s Victory Over Amgen in Filgrastim and Pegfilgrastim Biosimilar Patent Litigation

This morning, the Federal Circuit issued a precedential opinion affirming the district court’s judgment of non-infringement in favor of Sandoz in its BPCIA litigation against Amgen concerning Sandoz’s Zarxio® (filgrastim-sndz) biosimilar product and proposed pegfilgrastim biosimilar.  As we previously reported, in December 2017 the Northern California district court granted summary…

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PTAB Institutes PGR of Protein Refolding Patent at Issue in Filgrastim and Pegfilgrastim Litigations

U.S. Patent No. 9,856,287, which is directed to a protein refolding method, is one of the patents-in-suit in the pending Amgen v. Adello (filgrastim) BPCIA litigation and the sole patent-in-suit in the pending Amgen v. Apotex (filgrastim and pegfilgrastim) BPCIA litigation. As we previously reported, in November 2018, Adello and…

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Sandoz Initiates Declaratory Judgment Action Against Amgen Concerning Manufacturing of Filgrastim and Pegfilgrastim Biosimilars

On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…

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