Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…

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Hetero and Glenmark Launch Adalimumab Biosimilars in India

Hetero announced this week the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura.  Mabura is a biosimilar of AbbVie’s Humira and is indicated for the treatment of rheumatoid arthritis and other auto-immune disorders.  According to the company, Mabura is Hetero’s fourth biosimilar product. Glenmark also announced this…

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Bristol Myers Squibb, Bavarian Nordic, and Enzo Biochem file amicus brief supporting Amgen’s petition for en banc consideration of written description and enablement issues in Praluent® litigation

As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written description and enablement defenses.  Amgen…

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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…

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Momenta and Mylan Collaborating to Develop Biosimilar of Eylea® (aflibercept)

Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year.  According to the joint press release, the trial will be a randomized, double-blind, active-control, multi-center study in…

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