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.

FDA Approves Second Pegfilgrastim Biosimilar, a First for Coherus

Today, Coherus BioSciences announced that the U.S. FDA has approved Udenyca™ (pegfilgrastim-cbqv), its biosimilar of Amgen’s Neulasta®, for patients with cancer receiving myelosuppressive chemotherapy.  Udenyca™, which received marketing authorization in Europe in September, is Coherus’ first biosimilar to obtain approval in the United States.  Udenyca™ is the fourteenth biosimilar to…

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Amgen, Sandoz, Samsung, and Mylan Launch Biosimilars in Europe (UPDATED)

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October.  On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.  This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.  According to…

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NeuClone Commences Human Dosing of Biosimilar Trastuzumab in Phase I Clinical Trial

Last week, NeuClone Ltd. announced it commenced its Phase I clinical trial for its biosimilar Herceptin® (trastuzumab).  According to NeuClone, the Phase I trial is a single-dose, randomized, three-arm double blind study of over 100 healthy volunteers, conducted under the Australian Clinical Trial Notification (CTN) scheme.  According to NeuClone, “[t]his…

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District Court Denies Johnson & Johnson’s Motion to Compel Arbitration in Remicade Antitrust Suit

We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of Remicade® (infliximab). Pfizer’s suit alleges that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive bundling and rebate penalties for insurers and providers, causing inflated prices. In related litigation, retailers Walgreen and Kroger Co., direct purchasers,…

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Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti to host a Biosimilars Market Update Webinar

On November 6th, Goodwin’s Elaine Blais, Scott Lassman and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal…

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Sandoz Obtains FDA Approval for Adalimumab Biosimilar

The FDA announced today that it has approved Sandoz’s biosimilar Hyrimoz (adalimumab-adaz). The FDA had previously approved adalimumab biosimilars from Amgen and Boehringer Ingelheim. Sandoz’s global settlement with AbbVie regarding Hyrimoz provides Sandoz with a U.S. entry date of September 30, 2023, whereas Amgen is permitted an earlier U.S. launch,…

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Federal Circuit Certifies AbbVie's Constitutional Challenge in Consolidated Adalimumab IPR Appeals to U.S. Attorney General

As we previously reported, currently pending before the Federal Circuit are consolidated appeals from five final written decisions of the Patent Trial and Appeal Board (Board) in inter partes review (IPR) proceedings finding the claims of AbbVie’s U.S. Patent Nos. 8,889,135, 9,017,680, and 9,073,987 unpatentable for obviousness in view of…

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Post-Trial Briefing on Invalidity in Immunex v. Sandoz Etanercept Litigation

On September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar.  As we previously reported, prior to the start of trial, the Court had entered a stipulation of infringement of certain asserted claims of U.S. Patent No. 8,063,182 (“the ‘182 patent”)…

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