Welcome to the Big Molecule Watch!

Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

Court Grants BI Motion to Compel Discovery in Adalimumab Litigation (Updated)

On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”)  motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…

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Motion For Summary Judgement of Invalidity Denied in Praluent® Litigation

On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…

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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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