28 Oct 2014

Why Biosimilar has different approval process from generic drugs?

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Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing processes. Follow-on manufacturers do not have access to the originator’s molecular clone and original cell bank, nor to the exact fermentation and purification process, nor to the active drug substance. They do have access to the commercialized innovator product. Differences in impurities and/or breakdown products can have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the product. Therefore, regulatory agencies opt for different regulatory process for Biosimilar drug registration.

Why Biosimilars drawing market attentions?

The pharmaceutical industry landscape will change dramatically in the coming years. By 2016, generic alternatives will become available for some of the highest revenue drugs, including products such as Lipitor®, Plavix®, Seroquel®, Actos® and Singulair®, as the patents on those drugs expire. Estimates of the amount of worldwide revenue impacted by drugs going off-patent over the next five years range from about $80 billion to $250 billion; a significant percentage of the over $850 billion worldwide pharmaceuticals market. In addition to the “patent cliff” faced by branded pharmaceuticals, long awaited regulations providing an approval pathway for biosimilar drugs as alternatives to patent-protected brand name biologic drugs may further open the door to more generic drugs. With about 120 drugs going off-patent over the next ten years, the growing percentage of generics appears to represent a long term trend. This trend will pressure the sales and earnings of some companies, but may benefit others. Industries subject to rapid change often prove highly inhospitable to investors as unpredictable conditions frustrate efforts to assess underlying business values and durable competitive advantages.
So, in short Biosimilars are drawing market’s attention since there is an upcoming patent cliff, which will put nearly 36% of the 140bn USD market for biologic drugs at risk (as for 2011), this considering only the top 10 selling products

Biosimilar Regulation

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