mAbs (03/01/2015) Vol. 07, No. 2, P. 286; Socinskia, Mark A.; Curigliano, Giuseppe; Jacobs, Ira

Many governments have enacted legislation to approve biosimilar drugs, but limitations to their widespread uptake still exist. In the United States, the Food and Drug Administration has the authority to determine whether a product approved as a biosimilar may attain the higher level of evidence needed to be approved as an interchangeable biosimilar, but individual state laws also need to be applied. Evaluation of a biosimilar for extrapolation to additional indications is conducted on a case-by-case basis, and depends on the level of evidence provided by the applicant. Regulatory agencies are coming to different conclusions on the extent of extrapolation allowed. For instance, the European Medicines Agency recently granted approval of the full range of indications of the reference product to the biosimilar infliximab products Remsima and Inflectra, while Health Canada said the data provided did not support extrapolation to Crohn's disease and ulcerative colitis. Because clinicians will initially be unfamiliar with biosimilars as a new type of biological product, improved communication to physicians as well as payers and patients about the labeling and the rigor of oversight for biosimilars is necessary. The researchers concluded that despite the complex developmental and regulatory processes involved, the use of biosimilars for the treatment of cancer will provide additional treatment options, generate savings and efficiencies for healthcare systems, and free up resources for other healthcare treatments and interventions.

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