Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

(RTTNews) - The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat two rare diseases.

Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH and atypical haemolytic uraemic syndrome or aHUS.

Bkemv, a monoclonal antibody, is now approved for the treatment of patients with PNH to reduce hemolysis; and of patients with aHUS to inhibit complement-mediated thrombotic microangiopathy.

In the U.S., a disease is considered rare if it affects fewer than 200,000 people. The conditions PNH and aHUS are rare diseases characterized by the breakdown of red blood cells.

Interchangeable biosimilars are biosimilars that have been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber.

The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, similar to generic drug substitution for brand name drugs.

Bkemv, as an interchangeable biosimilar, is highly similar with no clinically meaningful differences to Soliris. It has the same safety warnings and is expected to have the same adverse reactions as Soliris.

Bkemv binds to the complement C5 protein and inhibits activation of the complement system, a part of the body's immune system. This binding prevents the breakdown of red blood cells in the bloodstream (intravascular hemolysis) in patients with PNH and aHUS.

The agency noted that Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy or REMS. It is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said, "Many rare conditions are life-threatening, and many do not have treatments. The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited."

Bkemv is the 53rd approved biosimilar in the U.S. The FDA has approved 13 of these as interchangeable biosimilars.

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