(Reuters) -The U.S. FDA approved Amgen’s Bkemv, the first biosimilar to AstraZeneca’s rare blood disorder treatment Soliris, on Tuesday.
Amgen’s drug will be marketed under the name Bkemv. Biosimilars are close copies of complex biological drugs.
The approval comes with a black-box warning about the risk of serious infections caused by a bacteria called neisseria meningitidis.
In 2022, the company said Bkemv met the main goal of a late-stage study, showing comparable safety and immunogenicity to Soliris.
AstraZeneca acquired the intravenous injection, Soliris, through a $39 billion buyout of Alexion Pharmaceuticals in 2020.
Bkemv is approved to treat two rare blood disorders caused when the immune system attacks and damages red blood cells and platelets.
The two disorders – called paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome – can cause anemia and kidney failure, respectively.
The FDA said that Bkemv is an interchangeable biosimilar, meaning that its highly similar with no clinically meaningful differences to Soliris.
Moreover, Amgen’s biosimilar offers a cost-effective alternative, potentially reducing the financial burden on patients and healthcare systems. Consequently, it’s a critical step towards sustainable healthcare solutions.
Consequently, the FDA approves biosimilar products like Amgen’s to foster competition, encouraging biotechnological advancements. Additionally, this stimulates pharmaceutical investment, driving future treatment developments for rare and chronic diseases.
Looking ahead, the FDA’s approval of Amgen’s biosimilar to AstraZeneca’s rare blood disorder treatment may have far-reaching implications for the biotech industry. This decision sets a precedent for future biosimilar approvals, potentially accelerating the availability of affordable and effective treatments.
As the FDA approves more biosimilar products, patients with rare conditions benefit from improved access to life-saving medications.
Ultimately, Amgen’s biosimilar approval promises to enhance healthcare outcomes and ensure equitable access to essential treatments.
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