Although Dr. Daikh has confidence that pharmaceutical companies with experience in developing biologics will maintain high quality control, “it will be incumbent upon the FDA to ensure that all biosimilars are manufactured to the same quality and purity standards applied to the parent drugs, regardless of where and by whom the biosimilars are produced.”
The ACR strongly suggests the following standards for biosimilars, Dr. Worthing testified:
- Long-term, post-marketing studies of approved biosimilars to monitor for adverse events;
- Distinct names for each biosimilar to ensure correct prescribing and dispensing, as well as monitoring and tracking; and
- Clear FDA labeling that indicates whether a drug is: a) a biosimilar or interchangeable product; b) lists all approved indications for the biosimilar; and c) specifies whether clinical data come from studies of the biosimilar or the reference biologic.
Currently, U.S. biosimilars will each have a four-letter suffix to identify their reference biologic, instead of a distinct brand name. Some rheumatologists fear this naming style will cause confusion.
“We need to be able to confidently prescribe these therapies to our patients and feel comfortable that proper mechanisms are in place for rheumatologists to monitor patient reactions to prescribed biosimilars,” said Dr. Worthing. “Rheumatologists have been working with biologics for quite some time, and our patients take them for lengthy periods of time to manage their conditions, so we have a unique understanding of the extreme complexities of these medications.”
The pharmaceutical industry also wants the new products to have memorable, meaningful names, said Geoff Eich, executive director, Amgen Biosimilars.
“It will be more accurate in the database if you can actually remember it and track any adverse events to the appropriate product,” said Mr. Eich. He’s optimistic that biosimilars will encourage robust competition that will fuel innovation. “There’s opportunity for biosimilars around the world to be very successful.”
Pathway to Approval
Biologics are expensive to produce and costly for payers and many patients, depending on their insurance coverage. Adalimumab and etanercept have retail costs of $3,000 and higher per monthly dose, although coupon programs can reduce out-of-pocket costs for some patients.
According to a report by the Centers for Medicare & Medicaid Services (CMS), 22 of the top 48 brand-only drugs covered by Medicare Part B coverage are biologics.
The costs of biologics have been rising steadily, year over year. For example, wholesale acquisition prices for two top biologics used to treat RA, adalimumab and etanercept, increased 9% annually from 2007 to 2012, according to a study by Prime Therapeutics, a pharmacy benefit manager, presented at the Academy of Managed Care Pharmacy Annual Meeting in April 2013. The study projected that if cost increases continued at the same rate each year, RA specialty drug costs would likely top $50,000 per person by 2022.2
