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Court Denies Amgen’s Motion to Dismiss and Motion to Stay Regeneron’s Antitrust Case

We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware.  The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).” …

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Chinese Market Biosimilar Update

This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab).  BAT1806 is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), and is the first tocilizumab biosimilar approved by any…

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BPCIA Aflibercept Litigation: Mylan Seeks Leave to Add a Declaratory Judgment Counterclaim of No Lost Profits or Injunctive Relief

As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan.  Regeneron had asserted 24 patents in its complaint.  As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation. …

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Celltrion’s CT-P6 Demonstrates Equivalent Safety, Efficacy With HERCEPTIN

A recently-published study reported that Celltrion’s CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with reference drug HERCEPTIN when used to treat patients with HER2-positive advanced gastric cancer.  This is the first study to directly compare the safety and efficacy of CT-P6 against HERCEPTIN in patients with advanced gastric…

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RELEUKO Receives FDA Approval

Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year.  RELEUKO references Neupogen®, and is expected to launch in the third quarter of…

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Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung Cancer

gloved hand withdraws drug solution with syringe

Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer.  According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free…

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FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE - 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…

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