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Biopharm Development & Manufacturing with CMO Lonza, and Samsung independently halted trials of rituximab. Media reports linked the decisions to halt tests to doubts about regulatory situations in the U.S. and Europe. If these companies reach the stage of submitting data to regulators, they will face a whole new set of uncertainties. The FDA is yet to accept an application under the biosimilars approval pathway, so nobody knows what will happen. PHYSICIANS NEED TO BE EDUCATED In small molecule generics, being the first to bring a copycat to market almost guarantees a big slice of the sector. But biosimilars, as in so many other areas, are more complicated. The path from approval to taking market share is less certain. For starters, though the U.S. law includes a definition of "interchangeability" that speaks to substitution without the intervention of the prescriber, it is a question of individual state laws whether pharmacists are permitted to switch patients from innovator drugs to biosimilars. Pfizer is of the opinion that the physician should own the decision to treat an individual patient with a biosimilar in view of the complexity of biologics in general, and, therefore, automatic substitution of biosimilars for innovator drugs without the intervention of the physician is inappropriate. Whatever the FDA decision, biosimilars manufacturers will need to work to win market share. The price difference between biosimilars and innovator products will be less pronounced than for generics. And the complexity of the products further shifts the risk-reward balance away from the biosimilar. The challenge will be similar in scale to marketing innovator biologics. Pfizer, with its background in innovative biologics, believes this gives it an advantage. "Our relationships with physicians across multiple therapeutic areas allow us to understand what they want from data," Nguyen says. Physicians are, along with regulators, pharmacists, and payors, one of the key stakeholders dictating how patients will access biosimilars. It is important they understand the issues. "Physicians need to be educated about differentiation, quality, and data perspectives in biosimilars," Nguyen states. With this understanding in place, physicians can make informed decisions about prescribing and help increase trusted acceptance of biosimilars. If biosimilars take market share, patients will benefit from more affordable versions of lifesaving biologics, and payors will gain a new tool to drive down healthcare costs. There is still a long way to go until this is achieved, though, and getting there will require creative thinking. "A cookie-cutter approach to biosimilars development simply isn't going to work," Nguyen concludes. We deliver more val-ue noun / 'val-(,)yü / 1: A fair return or equivalent in goods, services, or money for something exchanged. 2: A recent Industry Standard Research report highlighted LabCorp Clinical Trials as one of the top global central laboratories. Sponsors perceived that LabCorp offered the highest overall value among central labs while meeting customer expectations on price. LabCorp was also the only central lab to meet or exceed client expectations across all key service attributes. The report showed that LabCorp's top service attributes as rated by customers were "high value," "broad test menu," "geographic coverage" and "quality." Visit our website to learn more about LabCorp's extensive service portfolio as a global leader in biomarker testing. labcorp.com/clinicaltrials 38 LifeScienceLeader.com April 2013