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Amgen v. Hospira (epoetin alfa): District Court Lets in New Infringement Theories, Not New Defendants

As we previously reported, Amgen has sought to amend its complaint regarding Hospira’s planned epoetin alfa biosimilar to add three new defendants and two theories of infringement.  On October 3, 2016, Judge Andrews granted-in-part and denied-in-part Amgen’s motion.  First, the court denied Amgen’s request to add three defendants because “[i]t would be unreasonable to…

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CT-P10 Shows Equivalent Pharmacokinetic and Comparable Efficacy with Rituximab

Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid arthritis in the Annals of the Rheumatic Diseases.  The researchers reported that in the phase I trial CT-P10 and rituximab  “demonstrated equivalent pharmacokinetic and comparable…

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FDA Accepts Coherus’s aBLA for Neulasta® Biosimilar

In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.  Last week, Coherus announced that FDA has accepted its aBLA. Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a…

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New Results Presented at ESMO: Merck’s Keytruda® Has Potential to be Used as First-Line Therapy for Non-Small Cell Lung Cancer

At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic.  According to Merck’s press release, Keytruda performed better than the standard of care chemotherapy as a first line therapy for patients with metastatic non-small…

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