What is Mircera in the FDA Purple Book?

Mircera, BLA 125164, is listed as a 351(a) biologic with 19 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 125164?

Mircera, BLA 125164, lists Vifor (International) Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Mircera?

Mircera, BLA 125164, has 19 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Mircera's reference-product relationship?

Mircera, BLA 125164, does not state a reference product in the loaded FDA row. That bounded result is not proof about future eligibility or relationships outside this snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Mircera interchangeable?

Mircera, BLA 125164, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Mircera licensed by FDA?

Mircera, BLA 125164, has a listed FDA approval date of Nov 14, 2007. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Mircera's FDA label?

Mircera, BLA 125164, FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Mircera?

Mircera, BLA 125164, has no published patent rows in the loaded Purple Book patent data. That is a bounded source result, not proof that no relevant patent rights exist or a freedom-to-operate conclusion.

What exclusivity information is listed for Mircera?

Mircera, BLA 125164, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · 351(a) biologic

Mircera

methoxy polyethylene glycol-epoetin beta

Mircera, BLA 125164, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 19 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 125164 19 presentationsDiscLicensed Vifor (International) Inc.

Approved

Nov 14, 2007

License type

351(a)

Marketing

Disc

Listed patents

Mircera (methoxy polyethylene glycol-epoetin beta) is Vifor (International) Inc.'s FDA-licensed 351(a) biologic under BLA 125164, approved in 2007. No 351(k) product in the loaded Purple Book family data explicitly references Mircera; that bounded result is not a claim about future reference-product eligibility.

Sourced from the FDA Purple Book · verified Jul 02, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125164

Regulatory role

351(a) biologic

Applicant

Vifor (International) Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Nov 14, 2007

Reference product

Not stated

Mircera is an FDA-licensed 351(a) biologic.

No 351(k) product in the loaded Purple Book family data explicitly references Mircera.

Substitution boundary

The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Nov 14, 2007
19 yr ago
Today

Strengths & presentations

19 FDA presentation rows · BLA 125164

Strength

30MCG/0.3ML

Dosage form

Injection

Route

Intravenous, Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

2039

Product number

001

Submission type

Supplement

Supplement number

Change type

Not listed

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	30MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
002	50MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
003	75MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
004	100MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
005	120MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
006	150MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
007	200MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
008	250MCG/0.3ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
009	360MCG/0.6ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Rx
010	50MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
011	100MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
012	200MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
013	300MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
014	400MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
015	600MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
016	1,000MCG/ML	Injection	Intravenous, Subcutaneous	Single-Dose Vial	Licensed	Disc
017	400MCG/0.6ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Disc
018	600MCG/0.6ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Disc
019	800MCG/0.6ML	Injection	Intravenous, Subcutaneous	Pre-Filled Syringe	Licensed	Disc

Exact-source evidence coverage

Labeling & approval review

Current product label

Candidate awaiting exact-BLA match

FDA exposes a label link on this Purple Book row, but labeling content remains unavailable until the document is independently matched to this exact BLA and its presentations.

Inspect FDA label candidate

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

The current record does not expose a reference-product name or an exact linked 351(k) family for Mircera.

No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.

Published patents

BPCIA patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

19 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Intravenous, Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Vifor (International) Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Mircera is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v3Jul 02, 2026
v2Jul 02, 2026

Mircera: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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