The country of origin of HERZUMA® (trastuzumab-pkrb) for Injection, for intravenous use

N357240
January 21, 2026
OT:RR:NC:N3:138
CATEGORY: Origin Daejin Song Celltrion 19 Academy-ro 51beon-gil, Yeonsu-gu Incheon 22014 South Korea RE: The country of origin of HERZUMA® (trastuzumab-pkrb) for Injection, for intravenous use Dear Daejin Song: In your letter dated December 22, 2025, you requested a country of origin ruling on HERZUMA (trastuzumab-pkrb) for Injection. HERZUMA (trastuzumab-pkrb) for Injection, contains trastuzumab, a monoclonal antibody, as the active pharmaceutical ingredient (API). It is a biosimilar drug to HERCEPTIN (trastuzumab) and will be imported in 150 mg vials. HERZUMA is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In your letter, you requested a country of origin determination and indicated the active pharmaceutical ingredient (API) is also known as the drug substance (DS). You stated that the API or DS, is manufactured in South Korea and that the finished vials in dosage form are made in Portugal. In Portugal, the API (trastuzumab-pkrb) will be formulated and combined with excipients, filled into vials and lyophilized into powder form to produce the final dosage drug called “unlabeled drug product (uDP)” in 150 mg vials. Subsequently, the uDP in 150 mg vials are imported into Poland for labeling and packaging into the finished drug product (fDP) in dosage form. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) H301619, dated November 6, 2018. The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). In this case, we find the processing performed in Portugal and Poland does not result in a substantial transformation and the country of origin will be South Korea, where the API is made.

This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Judy Lee at [email protected].
Sincerely,
(for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division