Biotechnology

On February 9, the FDA released its guidelines on biosimilars, which propose an “abbreviated pathway” for approval that would vary by product. The biosimilar must be shown to be “highly similar” to the original. The requirements for clinical and animal studies would depend on an evaluation of analytical data, as well as scientific and manufacturing advances. Nine biosimilar clinical trials applications have been filed with the FDA. Post-marketing safety monitoring will be required and could include clinical studies. Datamonitor estimates the market for generic biotech drugs will reach $3.7 billion in 2015. Discounts for the drugs range from 25% to 45% compared with the branded originals’ prices. Branded biologic drugs have 12 years of market exclusivity in the US. Public comment on the guidelines will be accepted for 60 days.

Source: Reuters

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