Armstrong Comments on Coming Wave of BiosimilarsManaged Care June 15, 2010
Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice of Epstein Becker Green Wickliff & Hall's Houston office, was quoted in an article about how payers are beginning to make plans for a coming wave of biosimilars.
The article discussed how the Patient Protection and Affordable Care Act gives the FDA the authority to approve biosimilars after rigorous review. With the expected wave of biosimilar drugs expected to come on the market in two to three years, pharmaceutical benefit managers are working to evaluate how to position them in newly revised formularies.
Under the law, developers now have a set of legal rules then can follow, said Armstrong. The article mentioned that to gain approval of a biosimilar, developers will need to present a stack of trail data to prove that the new therapy produces the same health benefit with a comparable or better safety profile — the classic risk/benefit analysis that the FDA does every day.
Whether a biosimilar drug may be designated interchangeable is an important distinction, Armstrong said. "If your sales force is acting as a call center, an interchangeable product would be easier to market."
"When I was a pharmaceutical salesman we had free access to physicians," Armstrong stated. "Now there are greater pressures. Part of the reluctance of physicians to see phrama sales reps today is that so many products are me-toos. But I don't think the biosimilar will be seen as the me-too. Biosimilars will be marketed more like a competing brand where the manufacturer will have to educate the physician on the therapeutic effectiveness rather than merely promoting the biosimilar product."