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, niall.dinwoodie@crl.com
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