The country of origin of YUFLYMA (adalimumab-aaty) for Injection

N359909
April 17, 2026
OT:RR:NC:N3:138
CATEGORY: Origin Daejin Song Celltrion 19, Academy-ro 51beon-gil, Yeonsu-gu South Korea RE: The country of origin of YUFLYMA (adalimumab-aaty) for Injection Dear Mr. Song: In your letter dated March 20, 2026, you requested a country of origin ruling on YUFLYMA (adalimumab-aaty) for Injection. YUFLYMA (adalimumab-aaty) for Injection contains adalimumab, a monoclonal anti-tumor necrosis factor alpha antibody, as the active ingredient. It is a monoclonal antibody drug that is a biosimilar drug to Humira (adalimumab) and will be imported in 80 mg/0.8 mL single dose autoinjectors, prefilled syringes (PFS), and prefilled syringes with safety device (PFS-S). It is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. In your letter and in follow-up emails to this office, you indicated that the active pharmaceutical ingredient (API) manufacturing process is made in South Korea. In South Korea, the API is mixed with inactive ingredients to produce the final drug substance (DS) in bulk form. The DS is then exported to Belgium where it undergoes filtering, filling and assembly operations. In Belgium, the DS is subdivided into patient ready doses and filled into vials and aliquoted into 80 mg/0.8 mL dosage form. Specifically, the DS undergoes a filling operation where it is filled into syringes and becomes the unlabeled drug product (uDP). At this stage, the uDP syringes are assembled into autoinjectors, prefilled syringes (PFS), and prefilled syringes with safety device (PFS-S). Subsequently, the 80 mg/0.8 mL single dose autoinjectors and prefilled syringes (PFS and PFS-S) are transferred to Poland, where labeling and packaging operations are performed to produce the final drug product (fDP) in dosage form prior to export to the United States. 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, no substantial transformation occurs as a result of the operations performed in Belgium and Poland. Therefore, the country of origin of the finished drug product in dosage form (80 mg/0.8 mL autoinjectors and prefilled syringes) will be South Korea. 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) James P. Forkan Director National Commodity Specialist Division