OT:RR:NC:N3:138
Seungeun Jeong
Celltrion, Inc.
19, Academy-ro, Yeonsu-gu,
Incheon 22014
South Korea
RE: The country of origin of INFLECTRA® for Injection
Dear Seungeun Jeong:
In your letter dated July 4, 2025, you requested a country of origin ruling on INFLECTRA®
(infliximab-dyyb) for Injection, for intravenous use.
INFLECTRA® (Infliximab-dyyb) for Injection, imported in 100 mg vials, is a biologic treatment called a
biosimilar that contains the active ingredient, Infliximab-dyyb. The active pharmaceutical ingredient (API),
Infliximab-dyyb is a chimeric IgG1 monoclonal antibody (composed of human constant and murine variable
regions) specific for human tumor necrosis factor-alpha (TNF). Inflectra is a tumor necrosis factor (TNF)
blocker that is administered via intravenous (IV) infusion for the treatment of Crohn’s Disease; Pediatric
Crohn’s Disease; Ulcerative Colitis; Pediatric Ulcerative Colitis; Rheumatoid Arthritis; Ankylosing
Spondylitis; Psoriatic Arthritis; and Plaque Psoriasis.
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
(Infliximab-dyyb) 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 100 mg vials.
Subsequently, the uDP in 100 mg vials are imported into the United States 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 of the active ingredient (made in South Korea) with excipients into 100
mg vials in dosage form in Portugal does not result in a substantial transformation and the country of origin
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 Forkan
Acting Director
National Commodity Specialist Division