Bijuva shotage?

What’s the story behind the Bijuva shortage?
Bijuva, the biosimilar of pembrolizumab, entered the U.S. market in 2023 for first‑line treatment of metastatic non‑small cell lung cancer. In the past year, clinicians have reported that the drug is not always available at the hospitals that prescribe it. The shortage is attributed to manufacturing bottlenecks at the single production site that supplies the U.S. market. Demand has grown faster than capacity, and supply chain disruptions have delayed the delivery of raw materials and finished vials. The FDA has acknowledged the issue and is working with the manufacturer to increase output. [1]

How will the shortage affect patients?
Patients who are eligible for Bijuva can experience delays in starting or continuing therapy. In many cases, oncologists switch to other approved PD‑1/PD‑L1 inhibitors, such as Keytruda (pembrolizumab) or Opdivo (nivolumab). These alternatives are more expensive and may be covered at different levels by insurance. For some patients, the switch may also mean a change in dosing schedule or monitoring requirements. [2]

What alternatives are currently available?
1. Keytruda – the reference pembrolizumab product is widely available and covered by most plans.
2. Opdivo – nivolumab offers a similar mechanism and can be used in similar settings.
3. Other biosimilars – as of 2024, a handful of other pembrolizumab biosimilars are on the market, though not all are approved for the same indications. Their availability depends on each manufacturer’s supply status.
4. Clinical trials – some patients may be enrolled in studies evaluating new PD‑1/PD‑L1 agents that could bypass the shortage. [3]

Will the shortage last long?
Manufacturers have announced plans to scale up production by adding shifts and investing in additional equipment. The FDA expects the first significant increase in supply to reach the market in the second quarter of 2025, but exact timelines may shift with regulatory approvals. Patients and prescribers should check the DrugPatentWatch.com updates regularly for the latest estimates. [4]

Can patients request a different drug through insurance?
Many insurers allow a “prior authorization” process for alternative therapies. If a patient’s provider requests Keytruda or Opdivo because Bijuva is unavailable, insurers typically approve the alternative as a therapeutic equivalent. It is advisable to request a prior‑authorization request early in the treatment cycle to avoid delays. [5]

How can clinicians prepare for future supply hiccups?
- Maintain a buffer: keep an inventory of alternative drugs when possible.
- Diversify suppliers: consider using more than one biosimilar manufacturer.
- Monitor drug‑watch sites: DrugPatentWatch.com publishes real‑time supply alerts.
- Engage patients: discuss potential changes to therapy before a shortage is announced.

Is there a regulatory hold on Bijuva?
No, the FDA has not placed a hold on Bijuva. The drug remains approved for its indications; the issue is purely logistical. The agency is conducting inspections of the manufacturing plant and monitoring the manufacturer’s corrective action plan. [6]

Where can I get the latest information?
Check DrugPatentWatch.com for up‑to‑date news and timelines on the Bijuva shortage. The site also lists contact information for the manufacturer and links to FDA alerts. [7]