Albiglutide is the official generic name for a medication that was previously available under the brand names Tanzeum in the U.S. and Eperzan in Europe. This once-weekly injectable drug was a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated for the treatment of type 2 diabetes. Despite its approval and use, the manufacturer GlaxoSmithKline (GSK) made the decision in 2017 to voluntarily withdraw the product from the global market due to limited commercial uptake and declining sales, not for safety reasons. Consequently, no generic version of albiglutide was ever launched, and none is currently in development because the reference product is no longer available to serve as a benchmark for bioequivalence.
The Discontinuation of Albiglutide
GlaxoSmithKline's decision to discontinue albiglutide was primarily economic. The drug, which was approved by the FDA in 2014, faced stiff competition from other, more popular GLP-1 agonists already on the market. Despite being a once-weekly formulation that offered convenience, it failed to capture a significant market share. The company notified healthcare providers in 2017 to transition patients to alternative therapies, with remaining stock depleted by 2018. This voluntary market withdrawal effectively ended any prospect of a generic version being developed and approved in the traditional manner.
Why a Generic for a Biologic is Different
Unlike small-molecule drugs, which can have chemically identical generic versions, biologics like albiglutide are complex proteins. For biologics, the equivalent is a "biosimilar," which must be proven to be highly similar to the reference product with no clinically meaningful differences. The manufacturing process for biologics is intricate and constitutes a significant barrier to entry for potential competitors. With the reference biologic (Tanzeum/Eperzan) no longer available for comparison, the pathway to developing a biosimilar is essentially closed. For a company to produce a functional equivalent, they would need to pursue the more expensive and lengthy process of developing a new, novel drug from scratch.
Alternatives to Albiglutide
For former albiglutide users or those seeking a once-weekly GLP-1 agonist, several alternatives are available on the market today. These alternatives belong to the same drug class and work similarly to help control blood sugar in adults with type 2 diabetes. A healthcare provider can help determine the most suitable alternative based on an individual's health profile and treatment needs.
| Feature | Albiglutide (Tanzeum) | Dulaglutide (Trulicity) | Semaglutide (Ozempic) |
|---|---|---|---|
| Availability | Discontinued worldwide (as of 2018) | Currently available | Currently available |
| Status | Generic is the drug; discontinued product | Brand-name drug; no generic available yet | Brand-name drug; no generic available yet |
| Dosing Frequency | Once weekly | Once weekly | Once weekly |
| Mechanism | GLP-1 receptor agonist | GLP-1 receptor agonist | GLP-1 receptor agonist |
| Reason for Unavailability | Commercial/economic decision by manufacturer | N/A | N/A |
Important Considerations Regarding GLP-1 Agonists
When considering alternative GLP-1 agonists, it is crucial for patients to have a detailed discussion with their doctor about potential side effects, efficacy, and suitability. Like albiglutide, most drugs in this class carry a boxed warning regarding the risk of thyroid C-cell tumors, a finding from rodent studies. It is not yet known if this risk extends to humans. These medications are also not recommended for patients with a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Other potential side effects that can occur with GLP-1 agonists include nausea, diarrhea, and injection-site reactions. Although these drugs do not typically cause hypoglycemia (low blood sugar) on their own, the risk increases when they are used in combination with insulin or other glucose-lowering medications like sulfonylureas. Patients should be aware of the signs of low blood sugar and discuss necessary dose adjustments with their healthcare provider.
In conclusion, the question of "what is the generic for albiglutide" is answered by explaining the drug's complex market history. Albiglutide is the generic name itself, but its production and sale were stopped years ago. Former users of this medication should consult with a healthcare professional to explore the many other GLP-1 agonists currently available for the management of type 2 diabetes.
Summary of Albiglutide's Discontinuation and Generic Status
- Manufacturer Decision: The manufacturer, GlaxoSmithKline (GSK), discontinued the drug worldwide for commercial reasons.
- No Generic Follow-up: Because the branded product (Tanzeum/Eperzan) is no longer on the market, no generic or biosimilar has been developed.
- Biologic vs. Generic: Albiglutide was a biologic, and such drugs require the development of complex and costly "biosimilars," not simple generics.
- Alternatives Available: Numerous other GLP-1 receptor agonists are available for patients with type 2 diabetes.
- Safety Profile: While discontinued for business reasons, the drug and its class carry warnings regarding thyroid C-cell tumors based on animal studies.
