Ana Sayfa Biyoteknoloji Pfizer Remicade’in Biyobenzerini FDA Onayını Aldı

Pfizer Remicade’in Biyobenzerini FDA Onayını Aldı

ABD Gıda ve İlaç İdaresi,  yaptığı açıklamada, Pfizer Inc’in Johnson & Johnson’ın blockbusterı ve romatoid artrit ilacı olan  Reimcade’in ikinci biyo-benzerini onayladığını bildirdi.

Pfizer’s Ixifi was approved for all eligible indications of Remicade, including the treatment of bowel disease Crohn’s disease and skin disorder plaque psoriasis, the drugmaker said.

Biosimilars are medicines deemed highly similar to an original drug and are seen as cheaper alternatives to biologic products.

With the approval, Ixifi joins the ranks of other biosimilars that have claimed market share from Remicade, including Pfizer and Celltrion Inc’s Inflectra launched in late 2016, and Renflexis, made by Merck & Co and South Korea’s Samsung Bioepis Co Ltd.

Pfizer acquired Inflectra when it bought Illinois-based Hospira in 2015. At the time, the drugmaker elected not to discontinue development of Ixifi, which was already underway.

But the company has no plans to commercialize Ixifi, it told Reuters.

“We are currently evaluating our strategic options for Ixifi. But we are continuing to commercialize Inflectra in the U.S.,” a Pfizer spokesman said.

Ixifi comes with the same boxed warning as Remicade, cautioning against the risk of serious infections and malignancy.

Remicade is Johnson & Johnson’s bestselling drug and raked in revenues of $1.65 billion in the latest quarter.

Reporting by Tamara Mathias in Bengaluru; editing by Grant McCool