Stoboclo's interchangeable status, and why the date is later than Jubbonti's FDA Purple Book verified Sep 2026
Stoboclo was FDA-licensed as biosimilar in February 2025, but couldn't carry the interchangeable designation into the market until a competitor's exclusivity period cleared eight months later.
Celltrion's Stoboclo cleared FDA biosimilar licensure on February 28, 2025. But it could not enter the market carrying the interchangeable designation until October 29, 2025, because Jubbonti and Wyost — the first denosumab biosimilars designated interchangeable — held a 12-month first-interchangeable exclusivity that kept other denosumab biosimilars from launching as interchangeable until it expired. That expiration date, not Stoboclo's own regulatory timeline, is why Stoboclo's interchangeable-approval date lands eight months after its biosimilar license. Since October 29, 2025, Stoboclo has carried full interchangeable status. See the hub's full timeline for how this plays out across all nine biosimilar pairs.
Stoboclo vs. Osenvelt — one code, two doses CMS HCPCS + FDA verified Sep 2026
Celltrion sells denosumab-bmwo under two brand names for two dosing lines, and both bill Q5157.
| Brand | Dose line | Presentation | Regimen |
|---|---|---|---|
| Stoboclo (this page) | Prolia-equivalent, 60 mg | 60 mg/mL single-dose prefilled syringe | 60 mg subcutaneously every 6 months (osteoporosis) |
| Osenvelt | Xgeva-equivalent, 120 mg | 120 mg/1.7 mL (70 mg/mL) single-dose vial | 120 mg subcutaneously every 4 weeks (oncology; plus Day 8 and 15 doses in month 1 for giant cell tumor of bone) |
Because one code covers both brands, the biller has to look at the NDC on the syringe or vial actually used, not the code alone, to tell them apart on a chart note. The billed unit count is what a payer sees: 60 units means the 60 mg osteoporosis dose, 120 units means the oncology dose, regardless of which brand name is on the label.
Dosing FDA label verified Sep 2026
One dose, one interval, no induction phase, no weight adjustment — the same regimen as reference Prolia.
| Indication | Regimen | Notes |
|---|---|---|
| All labeled indications | 60 mg subcutaneously once every 6 months | Covers postmenopausal osteoporosis, male osteoporosis, glucocorticoid-induced osteoporosis, and bone loss from either aromatase-inhibitor or androgen-deprivation therapy. |
A biller confirming waste doesn't need to reach for a calculator here: the syringe holds exactly the amount that gets injected, which sets up the modifier rule below.
NDC reference — two active listings FDA NDC Directory, Sep 2026
Stoboclo carries two distinct NDC listings under the same BLA (761404) and the same labeler, Celltrion USA. Bill whichever code is printed on the syringe administered.
| NDC (10-digit) | NDC (11-digit, claim form) | Label | First marketed |
|---|---|---|---|
72606-037-01 | 72606-0037-01 | Brand-labeled "Stoboclo" | 2025-07-02 |
72606-058-01 | 72606-0058-01 | Generic-only "Denosumab-BMWO" | 2025-09-10 |
Administration codes CPT verified Sep 2026
One subcutaneous injection code covers the entire administration.
| CPT | Description | Use for |
|---|---|---|
96372 |
Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular | The only administration code for Stoboclo. Pays $15.36 nationally under the non-facility 2026 Medicare Physician Fee Schedule. |
96365 / 96366 |
Therapeutic IV infusion, initial hour / each additional hour | Not appropriate — there is no infusion. |
96401 |
Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | Not appropriate — denosumab-bmwo is not a chemotherapeutic agent. |
Modifiers — JZ, JW, and TB (340B) CMS verified Sep 2026
The fixed 60 mg dose matches the fixed syringe fill, so JZ is standard and JW is the exception.
JZ — required when no drug is discarded
CMS has required the JZ modifier on single-dose container claims with zero waste since July 1, 2023.
Stoboclo's 60 mg dose consumes the entire 60 mg syringe, so JZ belongs on the
Q5157 line for nearly every claim.
JW — required for documented waste
Reserve JW for the rare case where a syringe is opened but the full dose isn't given. Chart the discarded quantity and bill it on a separate line, same date of service, same HCPCS code.
TB — the only current 340B modifier
Hospitals billing Medicare for Stoboclo bought under 340B put TB on the drug line; CMS dropped the older JG modifier on January 1, 2025.
Modifier 25 — same-day E/M
Append modifier 25 only when a significant, separately identifiable evaluation happens beyond the pre-injection check-in already bundled into 96372.
Diagnosis codes for Stoboclo and Osenvelt Codes as on our Prolia and Xgeva pages
Q5157 covers two very different patients. Put an osteoporosis code on 60 units and a cancer code on 120 units.
Stoboclo, 60 units
| Indication | ICD-10 | Add or note |
|---|---|---|
| Postmenopausal osteoporosis | M81.0 | No current pathological fracture |
| Male osteoporosis | M81.8 | Other osteoporosis |
| Glucocorticoid-induced osteoporosis | M81.8 | Add Z79.52 (long-term systemic steroids) |
| Bone loss on aromatase-inhibitor therapy | Z85.3 | Add Z79.811; add M81.0 if osteoporosis is confirmed |
| Bone loss on androgen-deprivation therapy | Z85.46 | Add Z79.899; add M81.8 if osteoporosis is confirmed |
| Osteoporosis with current pathological fracture | M80.0xx- / M80.4xx- / M80.8xx- | Seventh character for initial vs. subsequent encounter |
| Localized osteoporosis (Lequesne) | M81.6 | Uncommon |
Osenvelt, 120 units
| Indication | ICD-10 | Add or note |
|---|---|---|
| Bone metastases from a solid tumor | C79.51 | Add the primary cancer code, or a Z85.x history code |
| Secondary involvement of bone marrow | C79.52 | Add the primary cancer code |
| Multiple myeloma | C90.00 | C90.01 in remission, C90.02 in relapse |
| Giant cell tumor of bone | D48.0 | — |
| Hypercalcemia of malignancy | E83.52 | Add the primary cancer code |
Low calcium (E83.51) has to be corrected before Stoboclo is given; it is never the billed
reason for a Q5157 dose. For the indication detail behind each row, see the
Prolia and Xgeva references.
Claim form field mapping CMS-1500 field reference
CMS-1500 / 837P (physician office; POS 11) example for a standard 60 mg Stoboclo dose.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC (either listing) + UN + quantity drawn (1 syringe) |
| HCPCS Q5157 + JZ (JW only if waste) | 24D (drug line) | 60 units for Stoboclo, 120 for Osenvelt |
| CPT 96372 | 24D (admin line) | One line, no second admin code |
| ICD-10 | 21 | Osteoporosis / bone-loss indication — see ICD-10 codes |
| PA number (when required) | 23 | Check the specific plan — see payer policies |
| TB modifier (340B sites only) | 24D | Hospitals, 340B-acquired drug, Medicare |
Payer policy snapshot — who prefers Stoboclo Reviewed Sep 2026, 27-payer corpus
Q5157 is on 9 of the 27 preferred lists surveyed: 8 name Stoboclo, and Centene names only Osenvelt.
Stoboclo (60 mg line) is preferred at BCBS Massachusetts, BCBS Minnesota, BCBS Mississippi, BCBS Nebraska, Florida Blue, Independence Blue Cross, UnitedHealthcare, and Wellmark BCBS. Centene/Ambetter prefers Osenvelt, Bilprevda and Wyost on the oncology side and does not name Stoboclo. Q5157 is non-preferred at Anthem, BCBS Louisiana, BCBS South Carolina and Excellus, and Regence lists Osenvelt as non-preferred.
Per the payer's policy, BCBS Mississippi's covered denosumab products are Stoboclo/Osenvelt, Bildyos/Bilprevda and Enoby/Xtrenbo; Prolia and Xgeva are no longer covered, and unnamed biosimilars are non-formulary. The web address on our copy of that policy belongs to a different policy, so check with the plan before relying on it.
All nine pairs, payer by payer, are broken out on the denosumab biosimilars hub.
Medicare reimbursement CMS Q4 2026 (live)
Refreshed every quarter from CMS's Part B Drug Pricing File.
Q4 2026 payment snapshot — Q5157 Stoboclo
Effective October 1 – December 31, 2026
Add the 96372 administration allowance ($15.36, 2026 Medicare PFS national non-facility rate) and a 60 mg Stoboclo claim totals $1,455.48 before sequestration, versus $1,806.72 for the equivalent Prolia claim.
Coverage
Q5157 is billed under CMS MCD Article A52399, the denosumab billing and coding article. Covered ICD-10 ranges by MAC are at Medicare covered diagnoses for denosumab.
Code source: the CMS HCPCS quarterly update file.
Patient assistance — Celltrion programs Status last checked May 27, 2026
Celltrion CARES Co-Pay Program is open. Eligible patients with commercial insurance may pay as little as $0; Medicare, Medicaid and other government plans are not eligible. It pays toward the drug only. Verify current terms at celltrioncares.com before quoting a figure to a patient.
Celltrion CONNECT Patient Support Program is also open and gives free drug to eligible uninsured patients. Both statuses come from a manual check on May 27, 2026, older than the September checks behind other denosumab programs, so reconfirm before enrolling a patient. Apply at celltrionconnect.com.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin code (infusion code used) | Biller defaulted to 96365/96366 or 96413/96415 out of habit from infused biologics | Resubmit with 96372 — the only administration code Stoboclo bills. |
| Wrong unit count (60 vs. 120) | Osenvelt's 120 mg dose billed under a Stoboclo claim, or vice versa — both share Q5157 | Confirm which product was actually administered against the NDC drawn and bill the matching unit count. |
| NDC/claim mismatch | Wrong one of Stoboclo's two NDC listings entered, or a listing entered that doesn't match the syringe drawn | Match the NDC in Box 24A to the exact package printed on the syringe used, whichever of the two listings it is. |
| Wrong HCPCS (J0897 or another biosimilar code billed) | Reference Prolia or a different biosimilar billed when the patient received Stoboclo | Match the HCPCS to the NDC actually drawn: 72606-037 or 72606-058 series = Stoboclo. |
| JZ missing | Single-dose-syringe claim without JZ when no drug was discarded | Resubmit with JZ on the Q5157 line — the norm on nearly every Stoboclo claim. |
| PA missing at a step-therapy payer | Claim submitted at a plan requiring prior trial documentation without it on file | Confirm the plan's specific step-therapy or preferred-product rule before scheduling; Stoboclo is favorably positioned at several payers but still requires PA at many. |
Frequently asked questions
What is the HCPCS code for Stoboclo?
Stoboclo (denosumab-bmwo) is billed under HCPCS Q5157 at 1 unit = 1 mg, matching reference
Prolia's unit basis. A standard 60 mg osteoporosis dose bills as 60 units.
Is Stoboclo interchangeable with Prolia?
Yes. The Purple Book's interchangeable date for Stoboclo is October 29, 2025. Its biosimilar license came on February 28, 2025, but Jubbonti and Wyost held a 12-month first-interchangeable exclusivity that ended on October 29, 2025, and that end date is what Stoboclo's interchangeable column shows.
Why does Stoboclo have two different NDC numbers?
Celltrion has two NDC listings under one BLA (761404): one under the
brand name Stoboclo (72606-037-01, first marketed July 2, 2025) and a second under a
generic-only label, "Denosumab-BMWO" (72606-058-01, first marketed September 10, 2025).
Both are listed as a 1 mL single-dose prefilled syringe; the reason for the second listing is not in our
data. Bill whichever NDC is printed on the syringe actually administered.
What is Osenvelt, and does it bill the same code as Stoboclo?
Osenvelt is the 120 mg Xgeva-line twin of Stoboclo, made by Celltrion from the same denosumab-bmwo active ingredient and billed under the same code, Q5157. Stoboclo doses 60 mg subcutaneously every 6 months for osteoporosis; Osenvelt doses 120 mg every 4 weeks for oncology indications. The claim units, 60 versus 120, distinguish them.
Does UnitedHealthcare prefer Stoboclo?
Yes. UnitedHealthcare's policy says Prolia and Stoboclo are its preferred denosumab products, so a Stoboclo request does not have to clear the Prolia-and-Stoboclo trial UHC asks of Jubbonti and other non-preferred products.
What is the Q4 2026 Medicare reimbursement for Q5157?
Q4 2026 ASP+6% for Q5157 Stoboclo is $24.002 per 1 mg unit, about 19.6% below reference Prolia's $29.856 in the same quarter. A 60 mg dose is 60 units, pricing to $1,440.12 before the administration allowance and sequestration.
Source documents
- FDA Purple Book Database — full monthly data file, August 2026 release
- DailyMed — STOBOCLO (denosumab-bmwo) prescribing information
- openFDA NDC Directory — denosumab listings
- CMS MCD Article A52399 — Billing and Coding: Denosumab and biosimilars
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — Medicare Part B inflation rebate guidance: use of the 340B modifier
- Celltrion CARES — Stoboclo co-pay program
- Celltrion CONNECT — patient support program
- CareCost Estimate — Prolia reference (J0897 and the full denosumab biosimilar family)
- CareCost Estimate — Denosumab biosimilars hub
About this page
Q5157's Medicare ASP is wired directly into our CareCost data layer, so it moves the moment CMS ships a new quarterly file. Everything else here — coding, payer policy, assistance-program status — gets a fresh look at least once a quarter, and sooner if Celltrion, the FDA, or a major payer changes something first.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Pulled straight from the CareCost ASP layer the moment CMS releases a new file. |
| Payer policies | Semi-annual | Hand-checked against each plan's published medical policy. |
| Assistance program status | Annual, or on manufacturer change | Confirmed on Celltrion's own program pages. |
| HCPCS / CPT / NCCI rules | Annual | Cross-checked against the CMS HCPCS quarterly file and current AMA CPT. |
| NDC, dosing, FDA label | Event-driven | Keyed to whenever DailyMed's structured product listing or the FDA label revision date changes. |
Who reviewed this
Change log
- — First version of this page. Covers Stoboclo (Q5157) specifically: the interchangeable-date gap versus Jubbonti, both of its NDC listings, the single 96372 admin code, JZ/JW/TB modifier rules, its Osenvelt twin, where 8 of 27 payers prefer Stoboclo (UnitedHealthcare included) plus Centene's Osenvelt-only listing, and the open status of both Celltrion CARES and CONNECT.
Methodology
Nothing on this page is estimated from memory. Dosing comes from Stoboclo's DailyMed label and the NDCs from the FDA NDC Directory; pricing is read live off the CMS Part B ASP file; each payer's stance is pulled from that payer's own published policy; and assistance status comes from Celltrion's program pages, not a third-party summary. A fact we can't trace to one of those gets left off the page rather than guessed at.