The U.S. International Trade Commission (USITC) has received a complaint alleging that certain biosimilar versions of the cancer drug pertuzumab imported into the United States violate U.S. trade law. The notice, published in the Federal Register, states that the complaint was filed on February 27, 2026, by Genentech, one of the world’s leading biotechnology firms.
According to the filing, the complaint alleges violations of Section 337 of the Tariff Act of 1930 in relation to the importation and sale of specific pertuzumab biosimilars in the United States. Section 337 investigations examine alleged unfair trade practices involving imported products, and the Commission has the authority to block imports if violations are found.
The complaint names several entities of Biocon as respondents. These include Biocon Ltd. and Biocon Biologics Ltd., both headquartered in India, as well as Biocon Biologics Inc. of Cambridge, Massachusetts, and Biocon Biologics International Ltd. and Biocon Biologics UK PLC, based in the United Kingdom.
The filing alleges violations “in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain pertuzumab biosimilars, including those made by certain methods of manufacturing, the active ingredient thereof, and products containing the same.”
Genentech has requested that the Commission impose trade remedies if a violation is established. Specifically, the complainant has sought a limited exclusion order to block imports of the allegedly infringing products, along with cease and desist orders. It has also asked the Commission to impose a bond on the respondents’ products during the 60-day Presidential review period that follows any remedial order.
The USITC has invited proposed respondents, interested parties, government agencies and members of the public to submit comments on public interest issues raised by the complaint. The Commission has asked commenters to address whether the requested remedies could affect public health and welfare, competition in the U.S. economy, domestic production of similar products, or consumers.
Pertuzumab is a monoclonal antibody used in the treatment of certain types of breast cancer, often administered alongside other therapies. Biosimilars are highly similar versions of existing biologic drugs and are typically introduced to offer more affordable treatment options once patent protections on original products expire.
The Commission will determine whether to institute a formal investigation following its review of the complaint.
