The US International Trade Commission (USITC) has received a complaint alleging that biosimilar versions of the cancer drug pertuzumab imported into the United States violate US trade law. The complaint, filed by Genentech on February 27, 2026, accuses certain entities of India’s Biocon, including Biocon Ltd. and Biocon Biologics Ltd., of infringing on Section 337 of the Tariff Act of 1930. The complaint specifically targets the import and sale of pertuzumab biosimilars in the US, seeking trade remedies from the Commission.
Genentech has requested the Commission to impose a limited exclusion order, cease and desist orders, and impose a bond on the alleged infringing articles during the 60-day Presidential review period. The USITC has invited the public and other interested parties to submit comments on the case, particularly focusing on public health and welfare, competition in the US economy, and the potential impact on consumers. The agency is also seeking input on the availability of similar products from other companies if imports were restricted.
Section 337 investigations by the USITC address alleged unfair trade practices involving imported products, with the authority to block imports upon finding violations. Pertuzumab, a monoclonal antibody used in treating certain types of breast cancer, is the subject of this complaint. Biosimilars, which are highly similar to existing biologic drugs, are often introduced as lower-cost treatment options after patents on original drugs expire.
