Amgen wins FDA approval for first interchangeable biosimilar to AstraZeneca’s Soliris


Amgen wins FDA approval for first interchangeable biosimilar to AstraZeneca’s Soliris

Published: May 29, 2024

By Tristan Manalac


The FDA on Tuesday approved Amgen’s Bkemv (eculizumab-aeeb) as the industry’s first interchangeable biosimilar to AstraZeneca’s rare disease drug Soliris (eculizumab).

Like its branded reference product, Bkemv is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It also carries a boxed warning for serious meningococcal infections, which according to its label can be “serious and life-threatening.” Because of this risk, Bkemv is only available through a restricted Risk Evaluation and Mitigation Strategies program.

Bkemv was also granted the FDA’s interchangeability designation, which allows it to be used in place of the branded reference product without needing to change the prescription. Depending on state laws, this substitution may take place at the pharmacy.

Interchangeable biosimilars fulfill additional data requirements and have demonstrated “no clinically meaningful differences” to their reference products, according to the FDA’s announcement. Patients and prescribers can “expect the same effectiveness” from the interchangeable product as they would the original reference drug.

Soliris is a recombinant humanized monoclonal IgG2/4 antibody that targets the C5 complement protein, according to its label, disrupting the complement cascade and preventing the formation of the terminal proteins in the pathway.

In PNH, this mechanism of action prevents the destruction of red blood cells, which would otherwise lead to its hallmark symptoms of anemia, fatigue, pain, shortness of breath, difficulty in functioning and blood clots.

Meanwhile, aHUS is driven by uncontrolled complement activity, leading to platelet activation, endothelial cell damage and thrombotic microangiopathy. Soliris’ mechanism of action helps temper the complement cascade, addressing the underlying disease pathway.

Soliris was first approved by the FDA in 2007 for PNH. At the time, it was still owned by rare disease player Alexion Pharmaceuticals, which AstraZeneca acquired in 2020 for $39 billion.

The investment has been paying off for AstraZeneca with Soliris consistently serving as one of its best-selling products. In 2023, Soliris was the pharma’s top rare disease asset bringing in $3.1 billion despite suffering a 14% decline in sales. Overall, Soliris was outperformed only by the cancer drugs Tagrisso (osimertinib) and Imfinzi (durvalumab), and the heart failure therapy Farxiga (dapagliflozin).

Source: BioSpace