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.

Amgen v. Hospira: Hospira Moves to Dismiss BPCIA Claims

As we reported in a previous post, Amgen is the plaintiff in another suit litigating the patent information provisions of the BPCIA, this time against Hospira.  Amgen’s complaint alleged that Hospira violated the BPCIA by (1) not providing manufacturing information within 20 days of FDA’s acceptance of Hospira’s biosimilar application for review…

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IPR Petition Up for Grabs

We recently posted about the PTAB declining to sanction CFAD for filing IPRs.  In light of that holding, Erich Spangenberg, owner of nXn Partners, revealed his intention to make publicly available substantially final draft versions of IPR petitions for pharmaceutical patents that he believes are invalid.  Spangenberg does not care who…

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Update in Amgen v. Apotex: Apotex’s Answer and Counterclaims

On October 5, 2015, Apotex filed its answer and counterclaims in the ongoing Amgen v. Apotex Neulasta® (pegfilgrastim) litigation. As we previously reported, Amgen’s complaint alleged that Apotex provided Amgen with an “ineffective” Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A), because “a subsection (k) applicant may only give…

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BREAKING NEWS: Deal Is Reached on TPP

It was announced this morning that the U.S. has reached an accord on the Trans-Pacific Partnership Agreement (TPP). As we reported in previous posts on this topic, one major point of dispute between parties to the negotiations was the length of the data exclusivity period that member-states would need to…

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Deal Watch: Amgen and Allergan Announce Positive Phase 3 Study Results for Their Avastin Biosimilar, ABP 215

Amgen and Allergan announced their biosimilar candidate ABP 215 “met its primary and secondary endpoints” in a Phase 3 study by demonstrating “clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab.”  ABP 215 is a biosimilar of Avastin (bevacizumab), a recombinant immunoglobulin G1 monoclonal antibody, for treatment of…

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