Unbranded Biologics vs Biosimilars: Reading the Product Identity

The identity the label can settle

When a pharmacist, pharmacy benefit manager (PBM) contracting committee, hospital formulary director, or market access strategist encounters a prescription carton, DailyMed structured product labeling (SPL) file, or National Drug Code (NDC) that omits a commercial brand name, a persistent industry reflex assumes the item must be either a small-molecule generic or an interchangeable biosimilar. In biopharmaceuticals, both assumptions fail. An unbranded biological product is neither a generic drug approved under an Abbreviated New Drug Application (ANDA) nor an automatically interchangeable follow-on competitor. Instead, it is an authorized unbranded presentation of an already licensed biological product, distributed under that exact product's own Biologics License Application (BLA).

The Food and Drug Administration (FDA) establishes this regulatory definition directly in Question 11 of its Purple Book Frequently Asked Questions: an unbranded biologic is an approved brand-name biological product marketed under its approved BLA without using the proprietary name on its label. Because the product shares the identical active drug substance, strength, dosage form, route of administration, and presentation as its brand-name counterpart, the FDA does not create a separate product entry or listing card for it in the Purple Book database. The entry remains indexed under the proprietary brand name and nonproprietary proper name of the underlying license. In the same breath, the FDA issues a vital category boundary: an unbranded biologic is not an interchangeable biosimilar. That sentence is an affirmative category warning against conflating unbranded status with a standalone demonstration of biosimilar interchangeability; it does not revoke or modify an underlying license's interchangeable status when the BLA itself was licensed under section 351(k).

Operating parallel to FDA licensure, the Centers for Medicare & Medicaid Services (CMS) codified an explicit program definition under Medicare Part D regulations at 42 CFR 423.4 (amended through the April 23, 2024 final rule, 89 FR 30448, document number 2024-07105). CMS defines an unbranded biological product as a biological product licensed under section 351(a) or section 351(k) of the Public Health Service (PHS) Act that is marketed without a brand name under the same BLA as its corresponding brand-name biological product. This definition reveals a critical structural reality: an unbranded biological product can originate from an originator reference biologic licensed under section 351(a), or it can originate from a biosimilar or interchangeable biologic licensed under section 351(k). The regulatory baseline is identical—the presentation shares the same license as the branded product.

Crucially, establishing this product identity marks a definitive boundary. Uncovering that an unbranded package shares a BLA with an originator biologic or an interchangeable biosimilar settles what product is inside the vial. It does not resolve downstream commercial or legal entitlements. It does not establish Medicare Part D formulary tier placement, does not dictate commercial payer prior authorization (PA) criteria, does not guarantee a lower patient copay, does not determine Wholesale Acquisition Cost (WAC) or Average Sales Price (ASP), and does not authorize a dispensing pharmacist to substitute the product for a prescribed reference biologic under state pharmacy practice acts. Product identity is the foundational document read that must occur before any coverage, pricing, or substitution evaluation can begin.

Worked record: NDC 83257-014-11

To observe how product identity resolves on paper, examine a real-world case study from the market: National Drug Code (NDC) 83257-014-11, distributed by Biocon Biologics Inc. When this 10 mL vial arrives in an inventory catalog, its commercial carton displays no proprietary name. To identify what product this package actually represents, the reviewer must examine the primary source document: the FDA Structured Product Labeling (SPL) preserved in the National Library of Medicine DailyMed repository (SetID 3ac85ebb-5594-59c8-77fd-df254329d151, effective January 23, 2026, Version 9).

Walking the Highlights of Prescribing Information in sequence reveals an unambiguous regulatory paper trail:

• Proprietary Name: Completely absent from the label header. The package is titled solely by its nonproprietary proper name: insulin glargine-yfgn.

• Identity Sentence: The very first sentence under the Highlights header provides the binding declaration: “This product is SEMGLEE (insulin glargine-yfgn).” The labeler identifies the unbranded vial as Semglee. FDA's Purple Book FAQ calls an unbranded biologic equivalent to the brand-name product because it is the same product under the same BLA, not because a separate comparison created a new license.

• Biosimilarity Statement: The label immediately states that Semglee (insulin glargine-yfgn) is biosimilar to Lantus (insulin glargine) for the indicated conditions of use, strengths, dosage forms, and routes of administration described in the prescribing information.

• Application Number: Under the regulatory data block, the SPL cites BLA 761201, with marketing status listed as active since July 28, 2023.

• Package Specifications: NDC 83257-014-11 is one 10 mL multi-dose vial (100 units/mL, 1,000 units). NDC 83257-015-31 is one 3 mL single-patient-use prefilled syringe (300 units), and NDC 83257-015-32 is a carton of five of those 3 mL syringes.

Querying BLA 761201 in the FDA Purple Book database completes the identity puzzle. The entry for BLA 761201 lists proper name insulin glargine-yfgn, proprietary name Semglee, license type 351(k) Interchangeable, reference product Lantus (BLA 021081), applicant Biocon Biologics Inc., and original approval date July 28, 2021. The listed dosage forms in the Purple Book record are a 1,000-unit/10 mL multi-dose vial and a 300-unit/3 mL autoinjector. While the SPL text describes the 3 mL unit as a prefilled syringe/pen delivery device, this minor semantic variation in device nomenclature does not constitute a distinct BLA or an alternative license.

Why does NDC 83257-014-11 not appear on its own independent Purple Book listing card? Because, under FDA FAQ Q11, it is the exact same biological drug substance and presentation as Semglee under BLA 761201. The absence of a separate card is expected and confirmatory, not a sign of an unregistered product. Furthermore, while the original FDA approval letter dated July 28, 2021 was addressed to Mylan Pharmaceuticals Inc. (evaluating eligibility for first-interchangeable exclusivity under section 351(k)(6) of the PHS Act), the Purple Book record reflects Biocon Biologics Inc. as the current applicant. In regulatory tracking, product identity strictly attaches to the approved BLA number, not to historical corporate transactions or applicant name changes.

Significantly, NDC 83257-014-11 is not unbranded Lantus. Lantus is licensed under Sanofi's originator application BLA 021081. NDC 83257-014-11 is an unbranded presentation of Semglee under Biocon's 351(k) interchangeable BLA 761201 that references Lantus. Conflating unbranded Semglee with unbranded Lantus creates dangerous assumptions regarding manufacturer rebate contracts, copay assistance eligibility, and state-law substitution notices.

A secondary nuance arises when auditing the branded Semglee SPL (SetID 8cf5544f-87d6-468b-f6ae-898b1fdb5d80). In that labeling file, the marketing acts use status code completed. The high dates include October 17, 2024, already past as of this September 26, 2026 review, and April 30, 2027 and May 31, 2027. A completed status paired with a future high date is ambiguous. It is not, by itself, proof that branded packages have stopped shipping or that coverage has changed.

When the unbranded product is not a biosimilar

To understand why an unbranded biologic cannot be presumed to be a biosimilar, consider the control case: Sanofi-Aventis U.S. LLC's unbranded insulin glargine U-300 presentations (NDC series 0955-2900 and 0955-3900). Distributed in 1.5 mL SoloStar and 3.0 mL Max SoloStar prefilled pens, these packages omit the brand name Toujeo from their carton headers.

Auditing the DailyMed SPL file for Sanofi's unbranded U-300 product (SetID 99ea856d-9562-443a-9422-1006a3cff2f4, effective May 30, 2025, Version 7) reveals a completely different regulatory profile:

• Identity Sentence: The Highlights section explicitly declares: “This product is TOUJEO (insulin glargine).”

• Application Number: The application cited is BLA 206538, with active marketing recorded since April 1, 2023.

• Absence of Biosimilarity: The prescribing information contains no biosimilarity statement whatsoever. There is no claim of biosimilarity or interchangeability to Lantus or to any other reference product.

• Purple Book Listing: Querying BLA 206538 in the Purple Book confirms a 351(a) standalone biologics license, originally approved February 25, 2015, indicated for 300 units/mL administration.

Sanofi's unbranded U-300 product represents the classic originator 351(a) unbranded biologic archetype. It is identical to branded Toujeo under BLA 206538. It is not a biosimilar to Lantus (BLA 021081), and it is not an unbranded presentation of Lantus. Toujeo is 300 units/mL under BLA 206538. Lantus is a different 351(a) license, BLA 021081, at 100 units/mL. The May 30, 2025 label says that patients controlled on Lantus (insulin glargine, 100 units/mL) should expect to need a higher daily dose of the U-300 product to maintain the same level of glycemic control. In the label's steady-state comparison, Insulin Glargine, U-300 0.4 units/kg had an approximately 27 percent lower 24-hour glucose-lowering effect, and a different distribution profile, than an equivalent dose of Lantus, in 30 patients with type 1 diabetes. That dosing statement is not a pharmacy-substitution statute and not a finding that the unbranded U-300 package is unbranded Lantus.

This control case proves why proprietary name omission is clinically and legally neutral. An unbranded label simply reflects marketing without a brand name under whatever BLA is specified on the carton. If the underlying BLA is a 351(a) originator license, the unbranded product is an originator presentation. If the underlying BLA is a 351(k) biosimilar license, the unbranded product is a biosimilar presentation.

Same core name, different license

A frequent source of formulary error in specialty therapeutics is assuming that products sharing an identical International Nonproprietary Name (INN) or core nonproprietary name share a regulatory pathway or licensing status. Within the long-acting insulin market, multiple products share the core nonproprietary name insulin glargine, yet represent distinct licensing pathways and regulatory classes under the PHS Act.

Consider Basaglar (BLA 205692), marketed by Eli Lilly and Company. Prescribers and formulary committees frequently lump Basaglar into the 'Lantus biosimilar' category. However, inspecting Basaglar's DailyMed SPL (SetID 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae) and Purple Book entry establishes that Basaglar is licensed under section 351(a) as a standalone biologic, approved December 16, 2015. Its label contains no biosimilarity statement, and its Purple Book card lacks a reference product field. Basaglar is not a 351(k) biosimilar, is not an interchangeable product, and is not an unbranded presentation of Lantus.

A class rule, separate from Basaglar's own application history, appears in FDA's guidance Interpretation of the “Deemed to be a License” Provision of the BPCI Act. The guidance explains that certain protein products, including insulins, were approved in NDAs under section 505 of the FD&C Act, including some 505(b)(2) applications, and were deemed licensed under section 351(a) on March 23, 2020. Approval under that deemed path is not a 351(k) biosimilarity determination, and the Purple Book does not carry over Orange Book therapeutic-equivalence ratings. The guidance does not name Basaglar. This article does not treat the current 351(a) card for BLA 205692 as proof of Basaglar's original application type. What the card and the current label show is a 351(a) license, no reference-product line of the kind used for 351(k) products, and no biosimilarity statement.

Conversely, multiple distinct 351(k) licenses exist that reference Lantus as their reference product, each carrying its own independent application number and proprietary name:

• Rezvoglar (BLA 761215): Proper name insulin glargine-aglr, licensed under section 351(k) to Eli Lilly and Company as an Interchangeable biosimilar to Lantus, approved December 17, 2021. For comprehensive comparative coverage, see our Lantus biosimilars access guide.

• Langlara (BLA 761412): Proper name insulin glargine-aldy, licensed under section 351(k) to Sunshine Lake Pharma Co., Ltd. as an Interchangeable biosimilar to Lantus, approved April 29, 2026. For clinical and launch details, consult our Langlara access guide.

Neither Rezvoglar nor Langlara is unbranded Semglee, or unbranded Lantus. Each has its own BLA and its own proper name. For the database distinction, see Orange Book vs Purple Book for launch teams and the small-molecule parallel in authorized generics versus ANDA generics.

What the suffix and the biosimilarity line do not finish

A frequent assumption is that an FDA four-letter suffix shows whether a product is a biosimilar, or that a label which never uses the word interchangeable means interchangeability was denied. Both assumptions are the wrong test.

First, consider the naming convention. In its March 2019 draft guidance update, Nonproprietary Naming of Biological Products, FDA describes a core nonproprietary name with an FDA-designated four-letter suffix (such as -yfgn, -aglr, or -aldy). The express purpose of the suffix is pharmacovigilance tracking—ensuring that adverse events reported in postmarketing safety systems like FAERS can be attributed to specific manufacturers and manufacturing facilities. The draft guidance explicitly states that the suffix convention applies across originators, related biologics, and biosimilars. Crucially, the FDA stated it does not intend to retrospectively append suffixes to transition biological products that were already licensed without a suffix (such as Lantus BLA 021081 or Basaglar BLA 205692). Therefore, the absence of a suffix does not mean two unsuffixed insulins are identical, and the presence of a suffix does not indicate whether a biologic is a biosimilar or an originator.

Second, consider the absence of the word 'interchangeable' on the Biocon unbranded label. In the Federal Register notice published September 18, 2023 (88 FR 63957, Docket No. FDA-2016-D-0643), the FDA issued draft guidance titled Labeling for Biosimilar and Interchangeable Biosimilar Products. In that draft notice, FDA recommended the same biosimilarity statement in the Highlights for biosimilar and interchangeable products, and explained that interchangeability information is more appropriately located in the Purple Book than in labeling.

The FDA's rationale is straightforward: product labeling is written for prescribers. Both biosimilar and interchangeable biological products must meet the identical rigorous standard of biosimilarity—meaning no clinically meaningful differences in safety, purity, and potency. Interchangeability, by contrast, is a legal and regulatory status that governs pharmacy-level substitution without prescriber intervention under state pharmacy laws. Because substitution happens at the dispensing counter rather than during prescribing, the FDA concluded that interchangeability status is more appropriately communicated in the Purple Book database than in clinical labeling.

On Biocon's unbranded insulin glargine-yfgn label effective January 23, 2026, the SPL text contains the biosimilarity statement to Lantus and does not contain the word interchangeable. That pattern is consistent with the draft labeling notice. It does not replace the Purple Book, where BLA 761201 is listed as 351(k) Interchangeable.

flowchart TD
    Start["Unbranded Biological Product Package"] --> Inspect["Inspect Prescribing Information & Packaging"]
    Inspect --> Extract["Extract BLA Number & Exact Identity Sentence"]
    Extract --> QueryPB{"Query BLA Number in FDA Purple Book"}
    QueryPB -->|"Licensed under Section 351(a)"| Originator["351(a) Standalone Biologic\n(e.g., Toujeo U-300 under BLA 206538)\nNo biosimilarity statement; not unbranded reference product"]
    QueryPB -->|"Licensed under Section 351(k)"| Biosimilar["351(k) Biosimilar / Interchangeable\n(e.g., Semglee under BLA 761201)\nSame BLA as branded biosimilar; references Lantus"]
    Originator --> Downstream["Evaluate Downstream Operational Layers"]
    Biosimilar --> Downstream
    Downstream --> PartD["Part D Corresponding-Drug Pair\n(42 CFR 423.4 & 423.100)"]
    Downstream --> StateLaw["State Pharmacy Substitution Law\n(State statute still governs substitution)"]
    Downstream --> PlanFormulary["Plan Benefit & Formulary Tiering\n(NDC-Specific Coverage & Net Cost)"]

The Part D pair, and the pair it is not

While FDA product identity settles what the drug is, federal healthcare programs apply distinct statutory frameworks to determine how products interact on drug formularies. In Medicare Part D, formulary management is governed by regulations codified in 42 CFR Part 423.

Under 42 CFR 423.100, CMS defines corresponding drug by establishing three distinct regulatory pairs:

• A generic drug or authorized generic drug of a brand-name drug (FD&C Act section 505);

• An interchangeable biological product of a reference product (PHS Act section 351(k) / 351(i)); or

• An unbranded biological product marketed under the same BLA as a brand-name biological product.

Notice the strict pairing boundaries codified by CMS. The unbranded biological product corresponds to the brand-name biological product marketed under the same BLA. Applying this to our worked example: NDC 83257-014-11 corresponds directly to brand-name Semglee under BLA 761201. Meanwhile, Lantus (BLA 021081) corresponds to Semglee / insulin glargine-yfgn as the reference product in an interchangeable biological pairing. NDC 83257-014-11 is not the unbranded corresponding drug of Lantus, because they do not share an application.

The significance of these pairings becomes apparent when examining immediate substitution rules under 42 CFR 423.120(e)(2)(i). A sponsor may make a negative formulary change to a brand-name drug, a reference product, or a brand-name biological product within 30 days after adding the corresponding drug. Those 30 days are the window for the change. They are not a general waiver of enrollee notice. Every condition below still has to be met:

• Cost-Sharing Tier: The corresponding drug is placed on the same or a lower cost-sharing tier than the brand-name drug or reference product being removed or shifted.

• Utilization Management: The corresponding drug is subject to the same or less restrictive prior authorization, step therapy, or quantity limits.

• Notice Requirements: Advance general notice under 42 CFR 423.120(f)(2) must already be in the formulary and other beneficiary materials, telling current and prospective enrollees that immediate negative formulary changes may occur. For immediate substitutions, that general notice is also provided to CMS during bid submission. Written notice to affected enrollees is retrospective under 42 CFR 423.120(f)(3): as soon as possible, but no later than the end of the month following the month in which the change takes effect. The ordinary rule in 42 CFR 423.120(f)(1), written notice at least 30 days before the change, applies to negative changes that are not this immediate exception.

• The Market Availability Condition: The sponsor could not have included the corresponding drug on its initial formulary submission because the corresponding drug was not yet available on the market at the time the initial formulary was submitted to CMS.

Furthermore, CMS treats non-interchangeable biosimilars under a completely different mechanism: the maintenance change pathway under 42 CFR 423.100. One maintenance change is a negative formulary change to a reference product within 90 days of adding a biosimilar biological product other than an interchangeable biological product of that reference product, on the same or a lower cost-sharing tier and with the same or less restrictive prior authorization, step therapy, or quantity limit. A negative-change request for a maintenance change is deemed approved 30 days after submission unless CMS notifies the sponsor otherwise, under 42 CFR 423.120(e)(3)(i). That path is not the immediate-substitution exception in 42 CFR 423.120(e)(2)(i).

Finally, market access analysts must note an explicit unresolved question in CMS policy: CMS has not issued a binding worked regulatory example clarifying whether an unbranded 351(k) presentation that holds an interchangeable designation (such as NDC 83257-014-11) can be deployed simultaneously by a Part D plan sponsor as both the same-BLA unbranded pair to its branded biosimilar and as the interchangeable pair to the originator reference product. Access teams must not assume CMS has blessed dual-pairing substitution.

Where the plan and the state take over

Once regulatory identity and federal program rules are established, market reality shifts entirely to state pharmacy practice acts and health plan contracting.

First, an FDA interchangeability determination does not itself compel pharmacy substitution. In February 3, 2022 user-fee testimony, FDA said an interchangeable biosimilar may be substituted for the reference product without the prescriber, depending on state pharmacy laws, and used Semglee and Lantus as the example. This article does not survey those statutes. For the notice workflow, see state-law interchangeable biosimilar substitution notices, as well as the regulatory outlook in FDA biosimilar interchangeability streamlined pathways.

Second, health plans and PBMs do not contract on BLAs; they contract on specific National Drug Codes (NDCs). Within a single BLA, different NDCs can have completely divergent commercial access profiles. A compelling demonstration of this principle is Civica's insulin glargine-yfgn presentations (DailyMed SPL SetID 72cfe377-52f6-0348-fc71-5d4ac1992ffb, effective July 24, 2025).

Auditing the Civica labeling reveals that Civica packages its product under BLA 761201—the same BLA as Biocon's Semglee and unbranded insulin glargine-yfgn. The highlights call insulin glargine-yfgn a biosimilar to Lantus. NDC 72572-422-01 is one 3 mL prefilled syringe, and NDC 72572-422-05 is five 3 mL prefilled syringes. Marketing status is active from October 30, 2025. Civica's highlights do not include the sentence "This product is SEMGLEE." The Biocon unbranded 10 mL vial and the Civica 3 mL syringes share BLA 761201 and name Lantus as the reference product. They are different labelers and different NDCs. The shared license does not say which NDC a plan prefers.

A commercial plan, an employer plan, or a Medicaid preferred-drug list can prefer one NDC inside BLA 761201, another NDC on that same BLA, branded Semglee, or Lantus. This article did not open a WAC, ASP, NADAC, or rebate file, and it does not rank those NDCs by price. FDA treats the unbranded presentation and the brand-name product on the same BLA as the same product. That sameness does not decide which NDC a plan covers.

Commercial, regulatory, and market access professionals must therefore isolate five operational layers when analyzing biopharmaceutical products:

• 1. FDA Licensure: Originator standalone BLA under section 351(a) versus biosimilar BLA under section 351(k).

• 2. FDA Product Identity: Same BLA presentation sharing strength and route (unbranded biologic) versus an independent application.

• 3. Medicare Part D Maintenance Rules: Defined corresponding-drug pairs under 42 CFR 423.100 and conditional immediate substitution requirements under 42 CFR 423.120(e).

• 4. State Pharmacy Law: Statutory authority for pharmacists to substitute an interchangeable biologic without prescriber intervention at the point of sale.

• 5. Plan-Level Formulary Access: NDC-specific tier placement, net cost after rebates, copay card dynamics, and prior authorization rules determined by individual health plans and PBMs.

By maintaining rigorous separation across these five tiers, biopharmaceutical leaders ensure that labeling facts, statutory standards, and commercial contracting realities are never conflated.

Sources

• U.S. Food and Drug Administration. Purple Book FAQs: Database of Licensed Biological Products (including Question 11 on Unbranded Biologics). Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Semglee (insulin glargine-yfgn), BLA 761201, Biocon Biologics Inc. Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Semglee (insulin glargine), BLA 210605, Mylan Pharmaceuticals Inc. (Status: Discontinued). Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Lantus (insulin glargine), BLA 021081, Sanofi-Aventis U.S. LLC. Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Toujeo (insulin glargine), BLA 206538, Sanofi-Aventis U.S. LLC. Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Basaglar (insulin glargine), BLA 205692, Eli Lilly and Company. Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Rezvoglar (insulin glargine-aglr), BLA 761215, Eli Lilly and Company. Accessed September 26, 2026.

• U.S. Food and Drug Administration. Purple Book Database Product Details: Langlara (insulin glargine-aldy), BLA 761412, Sunshine Lake Pharma Co., Ltd. Accessed September 26, 2026.

• National Library of Medicine DailyMed. Structured Product Labeling: Insulin Glargine Injection (insulin glargine-yfgn), Biocon Biologics Inc., SetID 3ac85ebb-5594-59c8-77fd-df254329d151. Effective January 23, 2026.

• National Library of Medicine DailyMed. Structured Product Labeling: SEMGLEE (insulin glargine-yfgn) Injection, Biocon Biologics Inc., SetID 8cf5544f-87d6-468b-f6ae-898b1fdb5d80. Accessed September 26, 2026.

• National Library of Medicine DailyMed. Structured Product Labeling: Insulin Glargine U-300 Injection, Sanofi-Aventis U.S. LLC, SetID 99ea856d-9562-443a-9422-1006a3cff2f4. Effective May 30, 2025.

• National Library of Medicine DailyMed. Structured Product Labeling: BASAGLAR (insulin glargine) Injection, Eli Lilly and Company, SetID 0ad21db3-2b1c-4ed9-a687-bdd6a74d0aae. Accessed September 26, 2026.

• National Library of Medicine DailyMed. Structured Product Labeling: Insulin Glargine-yfgn Injection, Civica, SetID 72cfe377-52f6-0348-fc71-5d4ac1992ffb. Effective July 24, 2025.

• Electronic Code of Federal Regulations (eCFR). Title 42, Chapter IV, Subchapter B, Part 423, Subpart A, Section 423.4: Definitions (including Unbranded Biological Product). Accessed September 26, 2026.

• Electronic Code of Federal Regulations (eCFR). Title 42, Chapter IV, Subchapter B, Part 423, Subpart C, Section 423.100: Definitions (including Corresponding Drug and Maintenance Change). Accessed September 26, 2026.

• Electronic Code of Federal Regulations (eCFR). Title 42, Chapter IV, Subchapter B, Part 423, Subpart C, Section 423.120: Access to Covered Part D Drugs (Immediate Substitutions). Accessed September 26, 2026.

• Centers for Medicare & Medicaid Services. Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Final Rule), 89 FR 30448 (document number 2024-07105). April 23, 2024.

• U.S. Food and Drug Administration. Approval Letter: BLA 761201 for Semglee (insulin glargine-yfgn), Mylan Pharmaceuticals Inc. July 28, 2021.

• U.S. Food and Drug Administration. FDA User Fee Reauthorization: Ensuring Safe and Effective Drugs and Biologics (Congressional Testimony on Interchangeable Biosimilar Substitution). February 3, 2022.

• U.S. Food and Drug Administration. Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry; Availability. 88 FR 63957 (Draft Guidance). September 18, 2023.

• U.S. Food and Drug Administration. Nonproprietary Naming of Biological Products: Update; Draft Guidance for Industry. March 2019.

• U.S. Food and Drug Administration. Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry. March 2020.