FDA.reportPublic FDA data

denosumab-dssb injection, solution - Samsung Bioepis Co., Ltd.

Manufacturer
Samsung Bioepis Co., Ltd.
Effective date
2025-02-13
Label type
Risk Evaluation & Mitigation Strategies
Version
1
Source
full-release
Hydrated at
2026-06-04 22:50:38

Label at a glance#

ProductOSPOMYV
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: Severe hypocalcemia

Application Number: BLA 761392 (and Unbranded Biological Product)

Application Holder: Samsung Bioepis Co., Ltd.

Initial REMS Approval: 02/2025

II. REMS Goal

REMS Goals

The goal of the Ospomyv REMS is to mitigate the risks of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with Ospomyv.

Objective 1: Inform healthcare providers on:

  • Risk of severe hypocalcemia in patients with advanced chronic kidney disease (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2)
  • Need to assess for presence of chronic kidney disease-mineral bone disorder (CKD-MBD) before initiating Ospomyv in patients with advanced chronic kidney disease.

III. REMS Requirements

REMS REQUIREMENTS

To inform healthcare providers about the REMS and the risks and safe use of Ospomyv, Samsung Bioepis Co., Ltd. must disseminate REMS communication materials according to the table below:

REMS APPLICANT REQUIREMENTS

Target AudienceCommunication Materials & Dissemination Plans
Healthcare providers who are likely to prescribe OspomyvREMS Letters: REMS Letter for Healthcare Providers, REMS Letter for Professional Societies with the quick response (QR) code and REMS Website link to the Prescribing Information.
  1. Mail REMS Letter for Healthcare Providers within 60 calendar days of the date Ospomyv is first commercially distributed and again 12 months later.
    1. If returned, attempt to obtain updated address information and send a second letter by mail within 45 calendar days of the date the first letter is returned. If correct address cannot be obtained, the attempt will be documented.
  2. Email REMS Letter for Professional Societies within 60 calendar days of the date Ospomyv is first commercially distributed and again 12 months later through the following professional societies and request the letter or content be provided to their members. If the first email is undeliverable, the REMS letter will be mailed within 30 calendar days. If the first email is marked as unopened, a second email will be sent within 7 calendar days. If the second email is undeliverable or marked as unopened, the REMS letter will be mailed within 30 calendar days:
    1. American Society of Bone Mineral Research
    2. American College of Rheumatology
    3. American Association of Clinical Endocrinologists
    4. Endocrine Society
    5. American Society of Clinical Oncology
    6. Bone Health and Osteoporosis Foundation
    7. North American Menopause Society
    8. American Academy of Family Physicians
    9. American College of Physicians
  3. Make available via a link from the Ospomyv REMS Website.
  4. Disseminate through field-based sales and/or medical representatives from the date Ospomyv is first commercially distributed for the duration of the REMS.
  5. Disseminate and prominently display at Professional Meetings where Samsung Bioepis Co., Ltd. or representative has a Ospomyv commercial presence from the date Ospomyv is first commercially distributed for the duration of the REMS.
Patient Guide and Prescribing Information
  1. Disseminate and prominently display at Professional Meetings where Samsung Bioepis Co., Ltd. or representative has a Ospomyv commercial presence from the date Ospomyv is first commercially distributed for the duration of the REMS.
  2. Disseminate through field-based sales and/or medical representatives during the initial and/or follow-up discussions with healthcare providers from the date Ospomyv is first commercially distributed for the duration of the REMS. Field-based sales and/or medical representatives to verbally review the risk messages contained in the Patient Guide and Prescribing Information during the visit with the healthcare provider.
Website
  • Make the REMS website fully operational and all REMS materials available through the website by the date Ospomyv is first commercially distributed.
  • Maintain the REMS website from the date Ospomyv is first commercially distributed for the duration of the REMS.
  • Include a prominent REMS-specific link to the REMS website on all product websites for consumers and healthcare providers. The REMS website must not link back to the promotional product website(s).

IV. REMS Assessment Timetable

REMS Timetable For Submission Assessments

Samsung Bioepis Co., Ltd. must submit REMS assessments at 18 months, 3 years, and 7 years from the date of initial approval of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date for that assessment. Samsung Bioepis Co., Ltd. must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the Ospomyv REMS:

Training and Educational Material

Patient:

  • Patient Guide

Communication Materials

  • REMS Letter for Healthcare Providers
  • REMS Letter for Professional Societies

Other Materials

  • REMS website

VI. Statutory Elements

REMS ELEMENTS

This REMS is required under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Communication Plan
  2. Timetable for Submission of Assessments

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betweenSPL related document2025-05-28Samsung Bioepis Co., Ltd., | Samsung Biologics Co., Ltd. | FARMACEUTICI FORMENTI SPA20250411_eccabcb8-14b2-4a0d-b2f7-1283e408be1a.zip!3e3b3dc5-54a4-405a-a16b-7e3d4c3a0e77.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OSPOMYVDENOSUMABCordavis Limitede1d80a82-de52-4a34-9df3-609e50667ffb2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OSPOMYV

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