Biologics
Balancing a biologics
Research into groundbreaking biologic therapies has significantly shifted the diagnosis and treatment paradigms for many disease categories, particularly in oncology, autoimmune, inflammation and neurology. Discovering and developing an innovative, first-in-class biologic has the potential to offer patients significant benefits as well as add substantially to a developer’s bottom-line as these medicines often become the new standard of care. But reaching this goal requires a difficult and seemingly insurmountable journey through the laboratory and the varying phases of clinical research.
By Dr Herren Wu D
pipeline portfolio Why biosuperiors represent a solid counterbalance to an innovative research and development programme
rug discovery and development is a highly complex and risky business. For every 5,000 pharmaceutical and biologic dis- coveries in pre-clinical testing, an estimated one to five products are ultimately approved for human use. Biologics currently represent a smaller portion of this pool of approved products. In spite of the risks involved, R&D programmes continue focus- ing on creating first-in-class therapies because of the potential gains, for the developers and the physician and patients they serve.
The high chance of failure associated with the biologic research and development process is mak- ing it necessary for many companies to diversify their resources in order to create a more balanced pipeline portfolio. The development of ‘biosimi- lars’ and ‘biosuperiors’ offers the potential to counterbalance the high risk nature of drug dis- covery and development. With the introduction of these types of biologics, some drug developers may now be wondering what is the best approach to optimally balance pipeline risk (Table 1).
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Lowering costs, mitigating risks While biologics – whether it is a biosimilar, biosu- perior or the original, innovative compound – are all complex treatments, they do not share the same regulatory pathway to approval or involve the same level of investment or risk.
A first-in-class product is associated with the greatest risk as it requires identifying a new target, and subsequently developing a therapeutic com- pound for that target and validating the target mechanism for disease intervention in human. All this does come at a price – companies involved in developing innovative, first-in-class biologics such as monoclonal antibodies must employ advanced technologies such as recombinant DNA, and mam- malian expression techniques. In addition, it requires manufacturing facilities with greater com- plexity than what is involved with small molecule drugs. By some estimates, the cost to bring an innovative biologic to market can run as high as $1.2 billion. But consider the rewards – the intro- duction of the first biologic therapies in oncology,
Drug Discovery World Spring 2011
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