Washington: The U.S. International Trade Commission (USITC) has received a complaint alleging that biosimilar versions of the cancer drug pertuzumab imported into the United States violate U.S. trade law.
Several entities of India’s largest biopharmaceutical company, Biocon, have been named as respondents.
The notice was published in the Federal Register. It said the complaint was filed by the world’s top biotech company, Genentech, on February 27, 2026.
“The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission’s Rules of Practice and Procedure filed on behalf of Genentech, Inc. on February 27, 2026,” the notice said.
The complaint alleges violations of Section 337 of the Tariff Act of 1930. It relates to the import and sale of certain pertuzumab biosimilars in the United States.
According to the filing, the complaint 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.”
Several Biocon entities are listed as respondents. These include Biocon Ltd. and Biocon Biologics Ltd., both based in India. Also named are Biocon Biologics Inc. of Cambridge, Massachusetts, Biocon Biologics International Ltd. and Biocon Biologics UK PLC of the United Kingdom.
Genentech has asked the Commission to impose trade remedies.
The complainant “requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents’ alleged infringing articles during the 60-day Presidential review period.”
The USITC has invited the public and other interested parties to submit comments.
“Proposed respondents, other interested parties, members of the public, and interested government agencies are invited to file comments on any public interest issues raised by the complaint,” the Commission said.
The Commission said comments should address whether the requested remedies would affect public health and welfare in the United States. It also asked whether they could affect competition in the U.S. economy, the production of similar products in the country, or U.S. consumers.
The agency is seeking specific input on how the products involved are used in the United States. It also asked whether other companies could supply similar products if imports were restricted.
The notice said commenters should also indicate whether the complainant, its licensees, or other suppliers “have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time.”
Section 337 investigations examine alleged unfair trade practices involving imported products. The Commission can block imports if it finds violations.
Pertuzumab is a monoclonal antibody used to treat certain types of breast cancer. It is usually given with other therapies. Biosimilars are medicines that are highly similar to existing biologic drugs. They are often introduced to provide lower-cost treatment options once patents on original drugs expire.
(IA
