New pathway for follow-on biologics raises concerns about drug quality, prices

July 1, 2010

The approval pathway created for follow-on biologic drugs, also called biosimilars, in the new healthcare reform package raises concerns related to drug prices and quality, dermatologists say. The Biologics Price Competition and Innovation Act gives originators of biologic drugs 12 years of data exclusivity.

Key Points

National report - The approval pathway created for follow-on biologic drugs, also called biosimilars, in the new healthcare reform package raises concerns related to drug prices and quality, dermatologists say.

The Biologics Price Competition and Innovation Act gives originators of biologic drugs 12 years of data exclusivity, although the Biotech Industry Organization (BIO), which represents branded biologic makers, wanted 14 years, according to a BIO fact sheet.

In this climate, "The medications are going to be more expensive" as manufacturers attempt to recoup development costs in 12 years, says Fitzgeraldo Sanchez, M.D., director of dermatopathology at Mid-Florida Dermatology, Orlando, Fla.

Cost a factor

Mark Lebwohl, M.D., professor and chairman of dermatology, Mount Sinai School of Medicine, New York, says there's no question that biologics - prescribed for treatment of psoriasis and psoriatic arthritis - cost too much.

"They're out of reach for many of our patients, and many insurers won't pay for them," he says.

But if manufacturers don't profit from these drugs, which are costly to develop and produce, "They're not going to develop them," he says.

Biosimilars are costly to make as well, Dr. Lebwohl says. "Because these are such large molecules, generics will not be identical" to pioneering products.

For example, he says biosimilars could be more immunogenic. If insurers require patients to use biosimilars that are less effective than branded biologics, "That could be a major disadvantage."

Disclosures: Dr. Sanchez reports no relevant financial interests. Dr. Lebwohl is a consultant for all biologic manufacturers, and his department receives grants for clinical trials from various pharmaceutical companies.