STEVE BERBERICH

From left: Students yu-Jung Wei and Michelle Campbell, MS; Gail Rattinger, PharmD, PhD, professor; Francis Palumbo; Melissa Ross, MA; F. Ellen Loh, MBA (student); and Francoise Pradel, PhD, associate professor. (Photo taken by Steve Berberich)

At the international conference Critical Issues Related to Regulation of Follow-on Biologics, presented by the School of Pharmacy Center on Drugs and Public Policy (CDPP) and held recently in Washington, D.C., leading pharmaceutical lawyers, professors, regulators, payers, and industry officials speculated on how impending federal guidelines might affect manufacturing and marketing of copycat biologic therapies—medications made from living organisms—that are not exactly the same as brand name biologic therapies.

Biologic therapies include vaccines, serums, viruses, antitoxins, blood products, proteins, and some organic products. After more than a decade of controversy and debate by brand name and generic drug manufacturing factions over the complexities of writing legislation regarding follow-on biologics, or biosimilars, the Food and Drug Administration (FDA) promised to release "guidances" by early this year.

“I think people at this conference represented the best cross section we could gather on this topic,” says Francis Palumbo, PhD, JD, professor at the School of Pharmacy and executive director of the CDPP. “And while the FDA has still not yet issued guidances, we can engage in speculation today.”

Asking patients, physicians, pharmacists, and insurance providers to accept a biosimilar as an alternative to a brand name biologic therapy is extremely complex, said Robert Dormer, JD, a founding member of the law firm Hyman, Phelps & McNamara, PC, in Washington, D.C.

Generic drugs made from chemical compounds are regulated by the FDA under the Hatch-Waxman Act of 1984, but biosimilars are not covered. The Affordable Care Act of 2010 gives the FDA authority to regulate them, but Palumbo says many scientific issues are unsolved and open for discussion.

Meanwhile, FDA guidances for biosimilars will evolve, with the agency starting out cautiously, said Dormer.

“Definitions of biosimilars require animal studies, clinical studies, analytical studies,” he said. “FDA has the legal authority to waive any of these, but most experts think it will be a while before the agency waives one or any of these.”

In 2005, the European Union published biosimilars guidances for its countries, yet only a handful of products have been marketed, due largely to the complex issues surrounding safety, effectiveness, and dosage, said Bruno Flamion, MD, PhD, chair of the Belgian Committee for Reimbursement of Medicines.

Sheila Weiss Smith, PhD, professor at the School of Pharmacy and director of the School’s Center for Drug Safety, said the categories of biosimilars that companies are likely to advance through FDA approval will “bridge the gamut between preventative and lifesaving drugs.” She added that the medical community needs new ways to communicate safety information about biosimilars that goes beyond what is on prescription labels.