Over the past several decades, advances in biotechnology and medicine have created an influx of biologics. Biologic products have shown great promise as effective treatments for cancer, autoimmune diseases, and other serious afflictions. Many drug manufacturers have been enticed by the promise of patent protection and strong market rates and have entered the field, developing innovative, therapeutic biologics. Consequently, there has also been a demand for generic follow-on biologics. There are two major factors limit the reach of biologic development: cost and safety. The need for an abbreviated approval system for follow-on biologics has been clearly demonstrated, and some options have been proposed. However, the most efficient and effective process would be a one year mandatory testing period to ensure that a follow-on biologic is the same as its reference standard so that necessary biologic treatments may be offered to the public at affordable prices.
A Pathway to Follow-on Biologics,
3 Hastings Sci. & Tech. L.J. 217
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