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.

Trastuzumab, Rituximab, and Bevacizumab Litigation Updates

Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Genentech’s Herceptin® (trasuzumab), Rituxan® (rituximab), and Avastin® (bevacizumab). Celltrion v. Genentech (trastuzumab) and Celltrion v. Genentech (rituximab) As we previously reported, on January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District…

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Delaware Court Denies Merck Summary Judgment Motion in Insulin Glargine Case

As we previously reported, Sanofi-Aventis sued Merck Sharp & Dohme in the District of Delaware for patent infringement based on Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) prefilled cartridge products. On January 2, 2018, Merck moved for summary judgment of non-infringement on the grounds…

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Evolus Announces Progress with Botox Follow-on Biologic

Last week, Evolus, Inc. announced updates to the regulatory progress of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox (onabotulinumtoxinA injection) product.  Evolus reported that FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd., Evolus’s contract manufacturer for DWP-450.  According to Evolus, the EIR confirmed the…

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Filgrastim, pegfilgrastim biosimilar litigation updates

Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) As we previously reported, in March, Amgen filed a complaint for patent infringement against Adello Biologics based on its filing of an aBLA for a filgrastim biosimilar. …

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HHS Seeks Public Comments on Trump Administration's Plan to Lower Drug Prices

Last week the Department of Health and Human Services (HHS) issued a request for comments on the Trump administration’s plan to lower drug prices.  The HHS blueprint to lower drug prices includes improving competition by promoting innovation and competition for biologics.  According to HHS, “FDA will issue new policies to improve availability, competitiveness, and adoption of…

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Apotex Proposed Merger of AUS & NZ Operations

Last week, Apotex Australia, an affiliate of the Canadian-based Apotex, Inc., announced a proposed merger of their Australian and New Zealand generic pharmaceutical and over-the-counter (OTC) operations with Arrow Pharmaceutical. This combined operation aims to offer pharmacists, patients and consumers a diverse range of almost 500 products, and permit the…

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Deal Watch: Catalent Biologics and Valerius Biopharma to Collaborate on Manufacture of Specialty Biosimilar Products

  Earlier this week, Catalent Pharma Solutions and Valerius Biopharma AG jointly announced their collaboration on the manufacture of Valerius’ specialty biosimilar products.  According to the press release, Catalent Biologics will provide cell line development and support cGMP manufacturing activities from Phase I through to commercial stages.  The collaboration will…

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Federal Circuit Addresses Standing in Decision on Appeal from PTAB

Last week, the Federal Circuit issued a decision in Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, in which the court held that Altaire had standing to appeal the PTAB’s final written decision in a post-grant review (“PGR”) of Paragon’s U.S. Patent No. 8,859,623 and reversed-in-part and vacated-in-part the PTAB’s Final Written Decision….

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FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered…

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President Trump’s Remarks on Lowering Drug Prices; Industry Reactions

On May 11, President Trump delivered remarks about his administration’s new plan to help lower drug prices.  The President blamed “soaring drug prices” on “everyone involved in the broken system,” including “the drug makers, insurance companies, distributors, pharmacy benefit managers, and many others,” such as “middlemen,” “special interests” as well…

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