Will The U.S. Learn From Other Nations' Biosimilar Interchangeability Regulations?

Frustration over the lack of FDA guidance on interchangeability and labeling reached a peak late last week following a speech by Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), in front of the Senate Subcommittee on Primary Health and Retirement Security. Woodcock was met with pushback from Sen. Elizabeth Warren, whose proposed pharma “swear jar bill” last winter disgruntled many pharmaceutical leaders. This time around, she reproached Woodcock over the length of time it’s taking the agency to release guidance on interchangeability and labeling — two hot topics on which the healthcare and pharmaceutical industries are waiting with bated breath for FDA insights.

When it comes to biosimilar interchangeability, the FDA is, naturally, focused on maintaining patient safety, especially since small changes in the manufacturing process of biologics can lead to changes in how the body reacts to the medicine. However, the U.S. is certainly not the only country confronting these concerns, and in recent weeks and months, some nations have made important decisions around interchangeability which will make a lasting impact on the growth of the global biosimilar market.

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