US FDA Approves sBLA of Pfizer for ABRILADA Interchangeability


The pharmaceutical company ‘Pfizer Inc.’ has now announced that, the US FDA has given approval for the reviewing the PAS (Prior Approval Supplement) to the BLA (Biologics License Application) for the ABRILADA as an interchangeable biosimilar to the Humira.

Mike Gladstone, president of inflammation and immunology at Pfizer said, an interchangeability designation for the ABRILADA is going to be helping them to support the increased use of the biosimilars by the pharmacists and also potentially leading for further costing the savings. He also said that, this announcement has been building on their commitment for broadening the access to the cost-effective, high-quality and essential treatment options for the patients that are living with certain chronic inflammatory diseases.

The PAS has also been supported by the positive data from the a study which has been responsible for evaluating the multiple switches between the treatment with the ABRILADA and the reference product known as Humira and both the medicines had been administered with the methotrexate in the adult patients having moderate to serious rheumatoid arthritis (RA).

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A biosimilar along with an interchangeable designation can possibly be substituted for the reference product by a pharmacist that has been subject to the individual laws of the state.