Biobetters and the Future Biologics Market - Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs. - BioPharm International

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Biobetters and the Future Biologics Market
Despite their difficult approval pathway, biobetters offer the potential for innovation and decreased healthcare costs.


BioPharm International
Volume 24, Issue 11, pp. 31-35

THE FUTURE BIOLOGICS MARKET

The global biologic market will grow—of that we can be certain—but what form will the market take? Globally, imitator products will continue to generate significant sales volume, if not value, in the less regulated markets. Some manufacturers of these products may be able to develop sufficiently detailed quality, safety, and efficacy data packages to convert the imitator to biosimilar status in the regulated markets. With established production facilities and sales generated from the imitator product, the additional investment to bring the product up to biosimilar status may be justified by the returns from biosimilar sales. Direct entry to the regulated markets as a biosimilar is less likely to be economically viable.

Biobetters offer the opportunity to establish brand-to-brand competition within treatment indications. Where in the past the identification of a mode of action has prompted the generation of multiple analogues, or "me-too" products, such as Lipitor, Crestor, Zocor, and Lipostat in the statin market, the identification of a target receptor by the originator product will spur the creation of biobetters. With many possible routes of modification, several companies will be able to target the same indication with novel products and thus create competition within the market.

New targets will continue to be identified, and the first product to be marketed for an indication may be more sophisticated than a simple copy of the natural human protein. As platform technologies are established, partnerships between innovators and the owners of the platforms will grow.

SUMMARY

The follow-on biologics area appears crowded with product divisions dependent on what seem to be slightly different regulatory definitions. Much attention has gone to biosimilars as the class with the potential to reduce healthcare costs through increased competition. With the experience gained from the introduction of these products in Europe and the conservative approach to regulation in the US, it is unlikely that biosimilars will meet this hope. However, biobetters represent an opportunity to be innovative with reduced risk and increased sales for the manufacturer while improving the treatment of patients and reducing healthcare costs. Why be similar, when you can be better?

Niall Dinwoodie is head of product characterization, Charles River, Edinburgh, UK,
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