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Federal Circuit Dismisses Momenta’s Appeal of Adverse Final Written Decision in Abatacept IPR

This morning, the Federal Circuit issued a precedential opinion dismissing Momenta’s appeal from the PTAB’s final written decision upholding the patentability of Bristol-Myers Squibb’s abatacept patents against Momenta’s IPR challenge. The Court dismissed Momenta’s appeal “for absence of standing/jurisdiction and for mootness.” As we have previously reported, although the Federal…

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Allergan Files ITC Complaint Against Evolus to Block Imports of Newly Approved Botox Follow-On

On January 30, 2019, Allergan and its partner Medytox filed a complaint with the ITC to block imports of Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection) product, DWP-450, manufactured by Daewoong Pharmaceuticals.  The complaint alleges that Daewoong misappropriated trade secrets of Medytox. Evolus filed a BLA for DWP-450 and it was accepted…

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European Commission Releases Pharmaceutical Anti-Competition Report

The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space.  The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and…

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Pipeline Updates: Pfizer, Amgen, and Allergan

Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development.  According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key…

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Biosimilar-Related Patent Litigation Updates

Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen filed this past August alleging patent infringement based on Apotex’s filing of aBLAs for pegfilgrastim and filgrastim biosimilar…

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Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars

Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar.  According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…

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Oversight Committee Launches “Sweeping Drug Price Investigation” Regarding Biologics

On Jan. 14, Rep. Elijah E. Cummings, the Chairman of the Committee on Oversight and Reform, issued a press release that his office had sent letters to 12 drug companies seeking “detailed information and documents about the companies’ pricing practices,”  including material regarding price increases, investments in research and development,…

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Tanvex’s New Drug Submission for Filgrastim Biosimilar to Health Canada

BioSimilars Patent Dance

Last October, we reported that Taiwan-based Tanvex BioPharma (“Tanvex”) announced that it had submitted a BLA to the FDA seeking approval of TX-01, a proposed biosimilar referencing Neupogen® (filgrastim) indicated for chemotherapy induced neutropenia. Last November, the FDA accepted Tanvex’s BLA for its filgrastim biosimilar. This week Tanvex has submitted a New Drug Submission (NDS) to…

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