미국식품의약국(FDA)이 스위스 노바티스 제약회 사의 백혈병 특효약 글리벡(성분명: 이마티닙)의 복제약(제네릭)을 처음으로 승인했 다고 AP통신이 5일 보도했다.
FDA는 인도의 복제약 전문 선(Sun) 제약회사가 만든 100mg과 400mg짜리 글리벡 복제약을 만성골수성백혈병(CML) 치료용으로 승인했다.
선 제약회사는 내년 2월1일부터 미국 시장에서 글리벡 복제약 판매를 시작할 것 이라고 밝혔다.
선 제약회사는 글리벡 복제약을 6개월 동안 독점 판매할 수 있게 된다.
따라서 6개월 후 FDA가 다른 제약회사의 글리벡 복제약을 승인하면 선 제약회사 의 복제약은 판매가격이 크게 떨어지게 된다.
2003년 처음 완치에 가까운 효과를 지닌 CML치료제로 처음 승인된 글리벡은 201 4년 세계에서 총 47억 5천만 달러, 미국에서만 25억 달러의 매출을 기록했다. (연합)
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FDA OKs first generic for Gleevec leukemia pill
U.S. regulators have approved the first generic version of one of the first very effective _ and expensive _ cancer drugs, Gleevec, which costs about $10,000 a month.
The Food and Drug Administration granted a subsidiary of Indian drugmaker Sun Pharmaceutical Industries Ltd. approval to sell generic Gleevec, known as imatinib mesylate, in 100-milligram and 400-milligram pills for chronic myeloid leukemia.
Mumbai-based Sun Pharmaceutical, a top maker of generic medicines, said Friday that it will begin selling the once-a-day pill in the U.S. on Feb. 1, 2016.
Gleevec, developed and sold by Swiss drugmaker Novartis AG, was approved in 2003. It was quickly hailed as a near-cure, transforming chronic myeloid leukemia from an almost universally fatal disease to one manageable with long-term medication. It’s also approved to treat acute lymphoblastic leukemia and several other cancer types, in adults and children.
Gleevec, known as Glivec in some other countries, is the top-selling drug for Novartis, with 2014 global sales of $4.75 billion, about $2.5 billion of that from U.S. sales.
It currently has a U.S. list price of about $10,000 per month for the more-common 400-milligram daily dosage.
Novartis, the world’s biggest drug maker by revenue and a leader in cancer medicines, is aiming to limit the number of U.S. patients who immediately defect to generic Gleevec.
Employing a common strategy of brand-name drugmakers whose blockbusters are going off patent, Novartis is offering patients with private insurance discount cards that set their monthly copayment at $10, with Novartis covering up to $30,000 a year of the pharmacy bill. Insurers would be on the hook for the remainder. The program isn’tt available to patients paying cash or insured under government health programs.
Sun has exclusive rights to sell generic Gleevec for six months. After that, if FDA approves other drugmakers’ generic versions, their prices should start dropping sharply. (AP)
