Symposium speakers weigh the gamble surrounding development of new biosimilar medicines
"These are fairly new entities in the marketplace,” moderator Cole Werble said as he kicked off a discussion that highlighted the uncertain prospects for biosimilars. The new drugs are imitations of powerful and expensive biologic medicines.
The panel discussion featured a trio of veterans from the pharmaceutical industry – Gillian Woolett, a senior vice president at Avalere Health; Carlos Sattler, vice president of Sandoz’s clinical development and medical affairs; and Molly Burich, associate director of public policy at Boehringer Ingelheim.
Biosimilars "looked like a confusing area” until nearly a year ago when U.S. regulators approved Zarxio, Werble said The drug, which was developed by Sandoz, is a copy of Amgen’s neupogen. Then in early April, regulators approved a second biosimilar, Inflectra, for treating Crohn’s disease.
Werble, who specializes in analyzing pharmaceutical and biotechnology policy, described the FDA’s progress on biosimilars as tortoise-like. "They are moving very slowly and very carefully," he said.
The panelists discussed the use of biosimilars in Europe, the challenges of developing the drugs as well as perplexing regulatory hurdles that remain in the U.S.
"One key thing is education of health care providers, payers as well as patients and legislators," Burich said. "It’s incredibly important that they all understand biosimilars."
The drugs, which are considered the equivalent of generics, are treated as more expensive brand drugs by administrators of key federal health care plans. The way prices for the biologics are calculated is important to drug makers who are investing billions of dollars to make them.
Woolett said the complexity that surrounds biosimilars leaves her skeptical about whether companies will continue to develop them. “The regulators are moving way too slow, the costs are way too big for these products to survive,” she said.
The Blanche and Irwin Lerner Center for the Study of Pharmaceutical Management Issues at Rutgers Business School hosts the symposium each year, offering students, faculty, alumni and professionals with insights on the latest industry trends. The research center's activities bolster the MBA in Pharmaceutical Management program at Rutgers. Hear Irwin Lerner, a former chief executive officer of Hoffman L Roche, describe his vision for the center and its annual symposium. "Irwin Lerner: The future of the biopharmaceutical industry."
The event also featured speeches by Robert Hugin, the executive chairman of Celgene, and Michael Kleinrock, the director of research development at IMS Health.
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