Amgen Gets FDA Nod for First Soliris Biosimilar

On Tuesday, the FDA gave its nod to Amgen's Bkemv (eculizumab-aeeb), marking it as the first interchangeable biosimilar for AstraZeneca’s Soliris (eculizumab), a treatment for rare diseases.

Bkemv, like Soliris, is approved for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It carries a boxed warning for severe meningococcal infections, which can be serious and life-threatening. Due to this risk, Bkemv is only available through a restricted Risk Evaluation and Mitigation Strategies (REMS) program.

The FDA's interchangeability designation signifies that Bkemv can be used as a substitute for Soliris without requiring a new prescription, depending on state laws. This substitution can occur at the pharmacy level.

Interchangeable biosimilars must meet additional data requirements and demonstrate no clinically meaningful differences from their reference products. According to the FDA, patients and healthcare providers can expect the same effectiveness from Bkemv as they would from Soliris.

Soliris works as a recombinant humanized monoclonal IgG2/4 antibody targeting the C5 complement protein. This action disrupts the complement cascade, preventing the formation of terminal proteins in the pathway.

In PNH, this mechanism prevents red blood cell destruction, avoiding symptoms like anemia, fatigue, pain, shortness of breath, functional difficulties, and blood clots. For aHUS, the drug addresses the uncontrolled complement activity that triggers platelet activation, endothelial cell damage, and thrombotic microangiopathy, effectively mitigating the underlying disease pathway.

Soliris first secured FDA approval in 2007 for PNH and was initially owned by Alexion Pharmaceuticals, a leader in rare disease treatments. AstraZeneca acquired Alexion in 2020 for $39 billion, and Soliris has since been one of its top-selling products. Despite a 14% dip in sales, Soliris generated $3.1 billion in 2023, making it AstraZeneca's leading rare disease product. It was surpassed only by cancer treatments Tagrisso (osimertinib) and Imfinzi (durvalumab), as well as the heart failure treatment Farxiga (dapagliflozin).

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