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.

Federal Circuit Declines to Block Sales of Amgen’s KANJINTI (trastuzumab-anns) Before Resolving Genentech’s Appeal

As we previously reported, Genentech has appealed the Delaware district court’s denial of its preliminary injunction motion that sought to bar sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar in the United States.  In conjunction with its appeal, Genentech also asked the Federal Circuit (1) to issue an injunction against Amgen pending…

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Trump Administration Announces Action Plan to Allow Safe Importation of Prescription Drugs

On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the…

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Genentech appeals district court’s refusal to block Amgen’s trastuzumab and bevacizumab biosimilars

As we previously reported, Amgen commercially launched two biosimilars in the United States earlier this month: KANJINTI™ (trastuzumab-anns), a biosimilar to Herceptin®; and MVASI® (bevacizumab-awwb), a biosimilar to Avastin®.  Amgen’s launch announcement on July 18, 2019 came shortly after a Delaware federal district court denied Genentech’s requests for a temporary…

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Mylan and Upjohn to Join Forces

Mylan N.V. and Pfizer Inc. recently announced that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, will combine to form a new company.  According to the press release, each Mylan share would be converted into one share of the new company.  Pfizer shareholders will own 57% of the combined new company,…

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FDA Approves RUXIENCE, Pfizer’s Rituximab Biosimilar Product

On July 23, 2019, the FDA approved Pfizer’s aBLA for RUXIENCE (rituximab-pvvr), a biosimilar of Genentech’s RITUXAN.  According to its approved package insert, RUXIENCE is indicated for the treatment of certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis. RUXIENCE is the twenty-second…

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BREAKING NEWS: Federal Circuit Affirms Coherus Victory Over Amgen in Pegfilgrastim Patent Dispute

As we previously reported, last year Amgen appealed a Delaware district court’s decision dismissing Amgen’s patent infringement complaint under the BPCIA against Coherus on the ground that Coherus’s biosimilar of NEULASTA (pegfilgrastim) could not be found to infringe Amgen’s patent under the doctrine of equivalents (Amgen’s only asserted basis for…

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FDA Approves Samsung Bioepis's HADLIMA (adalimumab-bwwd)

Earlier this week, the U.S. FDA approved Samsung Bioepis’s  HADLIMA (adalimumab-bwwd), a biosimilar referencing HUMIRA, for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HADLIMA is the fourth adalimumab biosimilar to receive approval in the U.S. According to…

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