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Regeneron Identifies Six Patents for Expedited Trial in BPCIA Aflibercept Case Against Mylan

As we reported last week, the Northern District of West Virginia court has ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan.  As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation.  Regeneron also agreed that “it will…

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Biogen Seeks a Preliminary Injunction in Natalizumab BPCIA Case Against Sandoz

Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab).  On October 20, 2022, the Court issued a sealed order on the parties’ joint stipulation and proposed schedule for a preliminary injunction motion.  A redacted version of the parties’ proposed schedule…

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Celltrion’s Bevacizumab Biosimilar Approved by FDA

Celltrion announced this week that the FDA has approved VEGZELMA (bevacizumab-adcd), a biosimilar to AVASTIN, for treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian…

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Regeneron Seeks Expedited Trial in BPCIA Case Against Mylan Regarding Aflibercept Biosimilar

As we previously reported, Regeneron filed a BPCIA complaint against Mylan on August 3, 2022, regarding Mylan’s proposed aflibercept biosimilar.  Just two days after filing its Complaint, Regeneron filed a motion requesting an expedited status conference and to schedule a trial for no later than June 2023.  Briefing on Regeneron’s…

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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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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar

Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd).  HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019.  The low-concentration product has been available in various markets outside the United States, with over…

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