Tagged as: Sandoz

Biogen Files Sealed Complaint Against Sandoz and Polpharma Biologics Regarding Natalizumab

On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics.  Biogen’s complaint is filed under seal.  Based on the list of 28 asserted patents, the case appears to be a BPCIA litigation related to Sandoz and Polpharma’s proposed natalizumab biosimilar.  The asserted…

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Sandoz New Global "Act4Biosimilars" Initiative - Big Molecule Watch

On May 31, 2022, Sandoz announced the launch of a new global initiative called “Act4Biosimilars” to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by…

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Recent Adalimumab Biosimilar Updates

On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®.  Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…

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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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Divided Federal Circuit Affirms Result in Immunex v. Sandoz Etanercept Litigation

We previously reported on the decision by the District of New Jersey (Cecchi, J.) to uphold the validity of U.S. Patent No. 8,063,182, related to “the fusion protein etanercept, the active ingredient in Immunex’s product ENBREL” and U.S. Patent No. 8,163,522, related to ENBREL’s method of manufacture.  As we reported…

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Biosimilars Approvals: Nepexto Receives European Marketing Authorization, Ziextenzo and Riximyo Receive Health Canada Approval

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product.  The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical…

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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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