Biologics
Biosimilars have become an attractive model for many payers and governments looking for a less costly alternative to the original innovation. While this may appear to be an advantageous way to reduce healthcare costs associated with biologic therapies, the benefits end here. As copycats, biosimilars fall short in offering patients and their physicians with any new,
Biosuperiors strive to be best-in-class products, yet may take less time to pull through the pipeline, compared to first-generation drugs. Although biosuperiors represent a higher risk in investment versus biosimilars, they have the potential to yield greater business benefits, such as market share and profitability.
clinically-meaningful
benefits beyond the existing therapy. Biosimilars, therefore, allow companies to enter a market and put pricing pressures on competitors without offer- ing much added value for patients. There are strategic alternatives in breaking into a new bio- logics market that optimise the balance between investment, risk and rewards.
Given the clinical applications, implications for new treatments and potential return on invest- ment, biologics are a growing priority for many drug developers. Some companies, including MedImmune, the global biologics unit of AstraZeneca, are beginning to increase their research and development investment in biosuperi- ors as part of their overall investment strategy to maintain a sustainable pipeline. These drugs offer stronger, long-term incentives as they have the potential to provide patients with true clinical ben- efits, whether that is a more effective therapeutic option, a better safety profile, or a more conven- ient dosing schedule. At the same time, biosuperi- ors can help to generate a more substantial return on investment for a developer. With comparative clinical superiority, biosupe- riors provide patients, physicians and payers greater value compared to biosimilar products.
While research and development programmes will continue to focus on discovering new disease targets and creating first-in-class therapies for patients, it is equally important to find a solid counterbalance to minimise a company’s pipeline risk exposure given the high-stakes nature of the industry. Biosimilars and biosuperiors each have their own advantages for a drug manufacturer, as well as the patient and medical communities it serves. But the development of biosuperior drugs truly strikes the right balance between providing life-changing medical treatments for patients and maintaining an innovative pipeline for continued business success. Given the benefits of biosuperi- ors, from both a business and a clinical standpoint, there is potential to significantly change the treat- ment paradigm for many disease areas. DDW
Dr Herren Wu is Vice-President at MedImmune where he serves as Head of Biosuperiors and Antibody Discovery and Protein Engineering. Dr Wu is leading the company’s expanded concentra- tion on biosuperiors development and focusing commercialisation on US, European, Japanese and other markets supporting biologic products.
Active Motif, Inc
Biocius Life Sciences BioFocus
BioTek Instruments, Inc BMG Labtech Gmbh
Cellular Dynamics International, Inc CISBIO International SA DiscoveRx Corporation
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Drug Discovery World Spring 2011
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