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.

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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FDA Approves Hospira's Epoetin Alfa Biosimilar (UPDATED)

For just the tenth time since the implementation of the BPCIA, the FDA has approved a biosimilar product.  Today, the FDA announced that it has approved Pfizer-subsidiary Hospira’s Retacrit™ (epoetin alfa-epbx) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV…

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Q1 2018 Earnings Roundup: Biosimilars Update

Over the past few weeks, numerous biologics and biosimilar companies released their quarterly earnings for Q1 2018 and held related earnings calls.  Below are some highlights: On April 17, Johnson & Johnson (J&J) reported a 22.5% year-over-year (YOY) decline in U.S. sales of Remicade® (infliximab), which it attributed “to increased discounts/rebates,…

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Global Biosimilar Development Updates

Over the past week, biopharmaceutical developers from around the world provided updates on the development and availability of a number of biosimilar products and candidates.  Below are some highlights. On May 2, Mundipharma, a global network of independent associated companies, announced that the trastuzumab biosimilar Herzuma® is now available in…

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Janssen v. Celltrion: Summary Judgment Update

The past week saw further developments in the ongoing patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®. First, on May 4, Janssen and Defendants filed competing motions for summary judgment. Both sets of summary judgment papers are directed to the same issue:…

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PTO Proposes Replacing Broadest Reasonable Interpretation Claim Construction Standard in IPR, PGR, CBM Proceedings

Today, the PTO announced proposed rulemaking to change the claim construction standard applied by the PTAB in IPR, PGR, and CBM proceedings.  In particular, the PTO proposes replacing the broadest reasonable interpretation standard for construing unexpired patent claims with the standard applied in federal district courts and ITC proceedings as…

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Deal Watch: Amneal and Impax Complete Deal to Form Business Combination

  Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. announced today that they have completed their business combination to form Amneal Pharmaceuticals, Inc. (“Amneal”).  According to the press release, with the completion of this business combination, Amneal is now the 5th largest generics business in the United States. Amneal also states…

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Coherus Resubmits BLA for Pegfilgrastim Biosimilar Candidate

Last June, we reported that Coherus BioSciences had received a Complete Response Letter (CRL) from the FDA for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim).  Later, in August, we reported that Coherus had anticipated resubmitting its BLA in response to the CRL. Today, Coherus announced that it has resubmitted its BLA…

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US FDA Issues CRL for Sandoz’s Rituximab Biosimilar Candidate

Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab).  Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in…

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Four More States Consider Biosimilar Substitution Bills

As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills.  Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list. Last week, the Alaska legislature passed SB 32, entitled “Prescriptions for Biological Products,” which allows substitution of “an interchangeable biological…

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