What We Do


Although there are recognized needs for the marketing of safe and effective follow-on biologics products in the U.S., significant intellectual property rights are inevitably involved in meeting these needs. Sughrue has been at the forefront of this law and provides strategic counseling regarding all aspects of the complex intellectual property issues raised by the Approval Pathway for Biosimilar Biological Products. The intricate US Pathway sets forth the law for the production, use and sale of follow-on biologic therapeutics in the U.S., including provisions designed for determining the outcome of intellectual property disputes. The issues raised by the US Pathway are familiar to us, as we have, for over fifty years, engaged in servicing our clients' intellectual property rights for biologic and biopharmaceutical inventions. Our attorneys’ legal and technical expertise enables us to provide valuable insights into the subtleties and complexities necessary to successfully navigate this new and rapidly developing area of law. Our services help our clients fortify, create and grow new business opportunities and ventures.

For more information regarding this aspect of our biotechnology practice, please contact any of the attorneys in our biosimilars group and/or email biosimilars@sughrue.com.  


Biosimilar State Laws Emerge

IP360 Reports Upholding of US Biosimilar Pathway, available here.

According to BNA/Bloomberg, Caution Ahead - Justices Scalia, Kennedy, Thomas and Alito Say PPACA Biosimilar Pathway Defective, available here

US Biosimilar Law Upheld by Supreme Court

FDA Announces Biosimilar Product Approval Developments

Sughrue Discusses Rapid Advances in U.S. and European Biosimilar Pathways

Sughrue Leads Debate on Issues in New US Biosimilar Pathway

Sughrue Attorneys Lead ABA Program on Biosimilars

Sughrue Attorneys to Lead International Conference on Biosimilars


The New U.S. Biosimilar Pathway: Rapid Development in the U.S. and Europe (as published in the BNA's Pharmaceutical Law & Industry Report, March 2011).

Biosimilars Pathway: A Far Cry from Hatch-Waxman" (as published in IPLaw 360, HealthLaw 360, Competition Law 360 and International Trade Law 360).

Biosimilar Pathway Powerpoint