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.

Lupin Announces FDA Acceptance of aBLA for Pegfilgrastim Biosimilar

Global pharmaceutical company Lupin Limited recently announced that the U.S. FDA has accepted its aBLA for a proposed pegfilgrastim biosimilar (reference product Neulasta®).  Lupin reported that the aBLA submission was supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.  Company CEO Vinita Gupta commented, “FDA’s acceptance of our…

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Merck Completes Organon Spinoff

As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company.   This month, Merck completed the spinoff, creating Organon.  Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets.  Organon…

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Celltrion Shares Recent Biosimilar Development News

Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA).  According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…

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Sanofi Files Opposition to Amgen’s Petition for Federal Circuit to Reconsider Decision Invalidating Praluent Patents

As we previously reported, in April 2021, Amgen petitioned for the full Federal Circuit to reconsider the decision of a three-judge panel that two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were…

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Biogen and Bio-Thera Announce Positive Phase 3 Results On Tocilizumab Biosimilar

Biogen Inc. and Bio-Thera Solutions, Ltd. today announced positive Phase 3 results on BAT1806, a proposed biosimilar to ACTEMRA®/RoACTEMRA (tocilizumab). According to the Biogen press release, the study met its primary endpoints, demonstrating equivalent efficacy and comparable safety to the reference product in patients with moderate to severe rheumatoid arthritis…

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Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis).  The authors concluded from this study that both biosimilars…

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Quebec Government Announces Shift to Biosimilar Drugs

On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs.  The announcement stated that similar to other Canadian jurisdictions, Quebec will eventually cover, with exceptions, only biosimilar drugs on the…

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Meiji Announces Promising Phase I Results for Ustekinumab Biosimilar and Initiation of Phase III Clinical Trial

On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States.  Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings.  Phase III…

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