Washington, March 4 (NationPress) The U.S. International Trade Commission (USITC) has acknowledged a complaint asserting that imported biosimilar versions of the cancer medication pertuzumab are in violation of U.S. trade regulations.

Multiple branches of Biocon, India’s largest biopharmaceutical enterprise, have been identified as respondents.

The announcement appeared in the Federal Register, indicating that the complaint was lodged by Genentech, the leading biotech firm globally, on February 27, 2026.

“The Commission has received a complaint and a submission in accordance with § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Genentech, Inc. on February 27, 2026,” the notification stated.

The allegation points to breaches of Section 337 of the Tariff Act of 1930, concerning the importation and distribution of certain pertuzumab biosimilars within the United States.

The complaint claims violations in the “importation into the United States, sale for importation, and sale within the United States after importation of certain pertuzumab biosimilars, including those produced by specific manufacturing methods, the active ingredient thereof, and products containing the same.”

The respondents listed include several Biocon entities, such as Biocon Ltd. and Biocon Biologics Ltd., which are based in India. Additional respondents include Biocon Biologics Inc. located in Cambridge, Massachusetts, Biocon Biologics International Ltd., and Biocon Biologics UK PLC in the United Kingdom.

Genentech has requested the Commission to enforce trade remedies.

The complainant “requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond on the respondents' alleged infringing articles during the 60-day Presidential review period.”

The USITC has opened the floor for public comments and inputs from other interested parties.

“Proposed respondents, other interested parties, members of the public, and relevant government agencies are invited to submit comments on any public interest issues raised by the complaint,” the Commission stated.

Comments should address whether the sought remedies would impact public health and welfare in the United States, and whether they could influence competition in the U.S. economy, the production of similar products domestically, or American consumers.

The agency is looking for detailed feedback concerning how the products in question are utilized within the United States. It also inquired whether other companies could provide comparable products if imports faced restrictions.

Commenters should specify whether the complainant, its licensees, or alternative 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 timeframe.”

Section 337 investigations scrutinize alleged unfair trade practices connected to imported products. The Commission has the authority to halt imports should it confirm violations.

​Pertuzumab is a monoclonal antibody utilized in treating specific types of breast cancer. It is often administered alongside other therapies. Biosimilars are highly comparable medications to existing biologic drugs and are typically introduced to provide more affordable treatment options once the patents of original drugs expire.