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.

Plantform and Bio-Manguinhos/Fiocrus to Partner on Pembrolizumab Biosimilar for Brazil

Last week, PlantForm Corporation, PlantPraxis Biotecnologia and Bio-Manguinhos/Fiocruz announced that they are entering into a research and development agreement to develop pembrolizumab, a biosimilar of Keytruda®, for the Brazilian Market.  According to the announcement, Bio-Manguinhos is a Brazilian government institution responsible for technology development and production of vaccines, reagents and…

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Genentech and Centus Notify Court of Settlement of Bevacizumab Litigation

On November 12, 2020, Genentech filed a complaint in the Eastern District of Texas alleging that the Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Yesterday, the parties filed a Joint…

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Mylan Invalidates Another LANTUS Patent at the PTAB

On March 26, 2021, the PTAB issued its Final Written Decision in Mylan Pharmaceuticals, Inc. v. Sanofi-Aventis Deutschland GMBH, IPR2019-01657, which involved Sanofi’s Patent RE47,614 (“’614 patent”) relating to its LANTUS (insulin glargine) product. The PTAB ruled in favor of Mylan and held all 18 claims invalid for obviousness in view…

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Amneal Acquires Kashiv Specialty Pharmaceuticals

On April 5, 2021, Amneal Pharmaceuticals, Inc. (“Amneal”) and Kashiv BioSciences LLC (“Kashiv”) announced that Amneal’s wholly-owned subsidiary, Amneal Pharmaceuticals LLC, has completed its acquisition of a 98% interest in Kashiv’s wholly-owned subsidiary, Kashiv Specialty Pharmaceuticals, LLC (“Kashiv Specialty”).  According to the release, Amneal has a portfolio of more than…

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Biosimilar Manufacturing Update

On March 25, 2021, biosimilar manufacturer mAbxience announced that it is expanding its León, Spain manufacturing facility with a new 4,000 L Custom Single Run (“CSR”) bioreactor.  mAbxience claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in…

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Phase 1 Clinical Trial of Aflibercept (Eylea®) Biosimilar Completed by Alteogen

Alteogen recently announced that it has successfully completed a Phase 1 clinical trial for its Eylea® biosimilar, ALT-L9.  Alteogen conducted the clinical trials in South Korea, where its headquarters are located.  In the clinical trials, ALT-L9 and Eylea® were randomly assigned to 28 patients with neovascular (wet) age-related macular degeneration (wet…

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Adalimumab Biosimilars Ready To Enter Australian, Korean, Japanese and European Markets

On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co.  HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…

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