What is the tocilizumab shortage right now?
The picture splits by source. FDA does not list tocilizumab. openFDA's drug shortage data returned no matches on Oct. 30, 2026 for tocilizumab, its biosimilar suffixes, or the Tyenne, Actemra, Tofidence and Avtozma brand names, and FDA's current shortage list has no tocilizumab entry.
The American College of Rheumatology (ACR) says otherwise for one brand. ACR says it is aware of a widespread Tyenne shortage as of July 1, 2026, attributes it to increased demand, and says Fresenius Kabi reported intermittent out-of-stock periods and could not give restock dates. FDA's absence of a listing does not prove normal supply.
Three limits apply to that report:
- It is dated. ACR's last dated shortage statement is The Rheum Advocate of July 30, 2026. The advocacy page carrying the alert is undated. It was still live on Oct. 30 with no resolution notice, but that does not establish October status.
- Its scope is unsettled. An undated ACR clinical alert describes regional supply constraints, while the advocacy page says widespread.
- It reaches the public through ACR. Fresenius Kabi's U.S. news page lists no Tyenne shortage or supply notice from June 2026 onward, only the Aug. 10 recall. Current Tyenne status needs confirmation from the manufacturer.
We found no comparable public report for Actemra, Avtozma or Tofidence. That absence does not show those brands have spare supply.
PRN has also seen increased requests for Tyenne vials this year.
Is Tyenne discontinued, or just difficult to source?
No source we reviewed says Tyenne is discontinued. FDA NDC data shows the 80 mg, 200 mg and 400 mg vials marketed since April 15, 2024, and DailyMed carries a label published in August 2026. ACR describes intermittent stock-outs with no restock dates, which in our reading points to a sourcing problem rather than a withdrawal.
One narrower item needs attention. FDA NDC data shows a package marketing end date of Dec. 31, 2026 for two Tyenne subcutaneous NDCs, 65219-584-01 and 65219-586-04. No source explains it. Two newer subcutaneous NDCs are listed, but treating them as replacements is only an inference.
What is causing it?
The only public cause is ACR's attribution to increased demand. Neither FDA nor a published Fresenius document confirms it, and no source gives a root cause beyond demand, such as capacity or a specific plant.
Related public facts, none shown to be a cause:
- Fresenius's growth report. Fresenius reported second-quarter Biopharma revenue of EUR 260 million, up 38% organically, with Tyenne the key driver. On the Aug. 5 call, per an Investing.com transcript, the CEO described Tyenne reaching 30% U.S. share, without defining the measure. This fits ACR's demand attribution, but that is our inference. The transcript text does not address Tyenne supply, so it neither confirms nor denies the shortage.
- The recall. Fresenius announced it on Aug. 10, after ACR's July 1 date. No source says it caused or worsened the shortage.
- UnitedHealthcare's July 1 change. It took effect on the date ACR gives, but the policies do not mention shortage or supply, and any connection is not public.
Which products and presentations are affected?
ACR's reporting names Tyenne without listing presentations. FDA NDC data lists four intravenous brands in 80 mg, 200 mg and 400 mg vials, and the table separates what public sources say about each.
| Product | NDC | Manufacturer | Status as of Oct. 30, 2026 |
|---|---|---|---|
| Tyenne 80 mg/4 mL vial | 65219-590-04 | Fresenius Kabi USA | Not on FDA's list. Named in ACR's Tyenne shortage report, which does not break out presentations. Not in the recall. |
| Tyenne 200 mg/10 mL vial | 65219-592-10 | Fresenius Kabi USA | Not on FDA's list. Named in ACR's Tyenne shortage report, which does not break out presentations. Not in the recall. |
| Tyenne 400 mg/20 mL vial | 65219-594-20 | Fresenius Kabi USA | Not on FDA's list. Named in ACR's Tyenne shortage report, which does not break out presentations. Lot 16UI07 is under an ongoing Class I recall. The recall names no other lot. |
| Tyenne 162 mg/0.9 mL subcutaneous | 65219-584-01, 65219-586-04 | Fresenius Kabi USA | Not on FDA's list. ACR's report does not break out presentations. FDA NDC data shows a package marketing end date of Dec. 31, 2026. No source says why. |
| Tyenne 162 mg/0.9 mL subcutaneous | 65219-596-01, 65219-598-10 | Fresenius Kabi USA | Not on FDA's list. In FDA NDC data since Sept. 1, 2025. ACR's report does not break out presentations. Not in CMS's October ASP crosswalk. |
| Actemra 80, 200 and 400 mg vials | 50242-135-01, 50242-136-01, 50242-137-01 | Genentech | Not on FDA's list. No public supply report found. No recall in FDA enforcement data. |
| Actemra 162 mg/0.9 mL syringe and ACTPen | 50242-138-01, 50242-138-86, 50242-143-01, 50242-143-86 | Genentech | Not on FDA's list. No public supply report found. |
| Tofidence 80, 200 and 400 mg vials (Organon label) | 78206-200-01, 78206-201-01, 78206-202-01 | Organon | Not on FDA's list. No public supply report found. Intravenous only. |
| Tofidence vials (legacy Biogen label) | 64406-022-01, 64406-023-01, 64406-024-01 | Biogen MA label | Not on FDA's list. FDA NDC data shows a marketing end date of Aug. 1, 2027. FDA and CMS data disagree on strength by NDC, so check the carton. |
| Avtozma 80, 200 and 400 mg vials | 72606-042-01, 72606-042-02, 72606-043-01, 72606-043-02, 72606-044-01, 72606-044-02 | Celltrion USA | Not on FDA's list. No public supply report found. |
| Avtozma 162 mg/0.9 mL subcutaneous | 72606-045-01, 72606-045-02, 72606-045-03, 72606-045-04, 72606-045-05, 72606-045-06 | Celltrion USA | Not on FDA's list. No public supply report found. |
The Tyenne 400 mg/20 mL recall
Separately from the shortage report, FDA enforcement record D-0827-2026 lists a Class I recall of Tyenne 400 mg/20 mL, NDC 65219-594-20, Lot 16UI07, Exp 08/31/2028, covering 4,643 vials. Its status is Ongoing as of FDA data updated Oct. 21. The reason given is glass particles found in an internal investigation. How the glass got there has not been made public.
The recall notice posted by FDA says the lot shipped March 3 to March 25, 2026 and is recalled to the user level, with facilities told to stop use and return all units. Fresenius's recall letter, as posted by the California Board of Pharmacy in August 2026, says no adverse event reports had been received for the lot to date and that the issue is limited to this lot. Neither document addresses availability of other lots or replacement product.
How is this affecting healthcare buyers and facilities?
- Planning without a restock date. ACR says Fresenius could not give restock dates, and no FDA listing gives buyers presentation detail to plan against.
- More exception paperwork. ACR's July 30 update says practices may need to work with payers to move patients to an alternative and submit expedited formulary exception letters citing the shortage. ACR offers members a template.
- Payer rules that still lead with Tyenne. In our reading of the Federal Employee Program policy and the Blue Cross NC form, neither contains a shortage exception for Tyenne. Facilities should not assume a shortage report alone will clear a step requirement.
- A brand position that varies by plan. Tyenne's status differs across payers and within UnitedHealthcare's own lines of business, so one stocked brand may not fit a site's whole payer mix. The policy documents give no reason for these positions.
- A recall check on top of the shortage. Only one lot is named, so buyers should check lots rather than treat every Tyenne vial as affected.
- Item-master and billing upkeep. Each brand bills under its own code: J3262 for Actemra, Q5133 for Tofidence, Q5135 for Tyenne and Q5156 for Avtozma, and CMS's crosswalk lists separate COVID-19 codes. CMS Medicare Part B limits are published quarterly by code. Tofidence appears under both Organon and legacy Biogen NDCs, and two Tyenne subcutaneous NDCs carry the Dec. 31 end date, so check item masters.
Tyenne's position in published payer policies
| Payer and line | Effective | Tyenne position | Other terms |
|---|---|---|---|
| UnitedHealthcare Commercial and Individual Exchange | July 1, 2026 | Non-preferred, alongside Tofidence | Actemra and Avtozma preferred. Members on a non-preferred product must change unless they meet the criteria. |
| UnitedHealthcare Community Plan | Sept. 1, 2026 | Preferred, with Tofidence and Avtozma | Actemra non-preferred. Florida, New Mexico and Wisconsin are excluded from the preferred-product language. |
| Florida Blue | Revised Aug. 1, 2026 | Co-preferred with Avtozma | Avtozma intravenous and subcutaneous added as co-preferred. Subcutaneous tocilizumab is not considered medically necessary in provider-administered settings. |
| Blue Cross NC | October 2026 form | Preferred, with Avtozma | Asks for trial of both before Actemra or Tofidence, with listed intolerance, contraindication and serious adverse event exceptions. |
| Federal Employee Program policy 5.70.012 | Oct. 1, 2026 | Step product on the pharmacy benefit | Tyenne trial required for Actemra, Avtozma or Tofidence requests adjudicated through the pharmacy benefit. Exceptions listed are clinical. |
Separately, Celltrion says Avtozma holds preferred listings at Express Scripts, Optum and CVS Caremark on private formularies, according to an Aug. 3 article that does not say whether the listings cover intravenous product. The claim is not independently verified. Roche's half-year report attributes a 9% constant-rate decline in first-half Actemra sales to biosimilars and mentions no Actemra supply problem, though it is not a current supply statement.
What should facilities do when supply is tight?
- Confirm Tyenne status at the source. Ask Fresenius Kabi and your wholesaler, by NDC, what is shipping and whether a restock date exists. Get the answer in writing where you can.
- Check the shelf for Lot 16UI07. Review any 20 mL Tyenne against the lot, NDC and expiry above, and follow the recall notice for stop-use and return steps.
- Map exposure by payer and line of business. List which plans at each site require, prefer or exclude each brand, using current policy documents.
- Prepare exception documents early. Save dated evidence of failed orders and manufacturer responses. ACR's undated alert also advises practices to audit patient rosters and report local outages through FDA's portal.
- Keep product decisions with clinical teams. Any change of product, route or schedule belongs to the prescriber and P&T, working from the current label and the patient's payer policy. Do not treat a biosimilar as a purchasing-level swap.
- Check benefit fit before assuming subcutaneous helps. UnitedHealthcare and Florida Blue policies generally treat self-administered subcutaneous product as pharmacy-benefit, so it is not automatically usable in an infusion setting.
- Avoid panic buying. Order to documented need, since aggressive accumulation can make fill rates less predictable.
Where can buyers monitor supply information through PRN?
Because FDA does not list tocilizumab, buyers need public sources plus direct manufacturer confirmation. Start with the Drug Shortage News hub for market context, the drug shortage index for category review, and High-Demand Products for adjacent pressure points. The FAQ covers operational questions.
PRN can help facilities source tocilizumab by NDC and plan around payer and supply constraints. Use Request a Custom Quote for a specific presentation. New licensed facilities can start through customer onboarding, and teams that want background on PRN's support model can review Who We Are.
Need help sourcing tocilizumab by NDC or planning around Tyenne constraints? Use Request a Custom Quote for shortage-related sourcing support, or start customer onboarding if your facility needs a purchasing account.
Important note: This article is intended for general informational and procurement reference only. It is not medical, legal, or regulatory advice. Facilities should confirm current shortage status, recall status, lot numbers, labeling, route, payer policy, interchangeability, and purchasing decisions through current manufacturer, distributor, FDA, pharmacy, and institutional review channels before acting.