Welcome to the Big Molecule Watch!

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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.

Korea Approves Biosimilar of Remicade

On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative…

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UPDATED: Amgen Hoping to Capitalize on Preliminary Injunction Win in Florida in Other Litigation

After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…

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Hearing on Preliminary Injunction in Amgen v. Apotex

Last Thursday, December 3, the U.S. district court for the Southern District of Florida heard oral arguments on Amgen’s motion for a preliminary injunction in Amgen v. Apotex. As we’ve discussed in previous posts (here, here, and here), Amgen is seeking a preliminary injunction to prevent Apotex from launching its…

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FDA’s Interim Response to AbbVie’s Citizen Petition

As we’ve previously reported, AbbVie filed a Citizen Petition on June 2, 2015 demanding that FDA impose particular labeling requirements on biosimilar applicants, and several other entities subsequently submitted comments on AbbVie’s petition.  On December 1, 2015, FDA issued an interim response to AbbVie’s petition indicating that “FDA has been…

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HHS Holds Forum on Affordable Healthcare

On November 20th, the U.S. Department of Health and Human Services (HHS) held a forum entitled “HHS Pharmaceutical Forum: Innovation, Access, Affordability and Better Health.” A list of the speakers and their biographies is available here, and a link to video recordings of the proceedings is available here. The forum…

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European Medicines Agency Recommends Market Authorization for First Etanercept Biosimilar

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.  This is the second biosimilar antibody drug that…

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