FDA Gives Biosimilars a Boost by Expanding Database

Published April 13, 2020

In a move that could increase competition and bring down prices, the U.S. Food and Drug Administration (FDA) is expanding its list of licensed biologic products to include biosimilars and interchangeable biologic products and transitioning that list to an accessible online database.

Biologics are powerful drug products used to treat a wide range of diseases. Because they are produced in living organisms, biologics are difficult to replicate and can be costly. In 2018, spending on biologics totaled $125.5 billion.

The so-called “Purple Book” is a list of all licensed biologic products and is a reference guide for patients, providers, payers, and manufacturers. Searchers can find products considered to be interchangeable medications, the date the product was licensed under the Public Health Service Act, and information about the drug’s exclusivity.

The transition to an online database will happen over multiple stages, and once completed, the Purple Book will be phased out. Biological products controlled by the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will continue to be identified on separate lists.

In a press release, the Biosimilars Council’s executive director Christine Simmon praised the move announced on February 24.

“Today’s FDA action to enhance the Purple Book is a boon to those seeking to bring biosimilars to America’s patients,” Simmon stated. “By increasing the utility of the Purple Book, the agency is helping to close both educational and regulatory gaps that will foster patient access to FDA-approved biosimilars and increase their utilization to lower prescription drug costs.”

Pushing for Replication

To encourage further competition, the council has urged lawmakers to support the Biologic Patent Transparency Act (S. 659), which would require the Purple Book to include patents for the referenced biologic products.

In a news release, Sens. Susan Collins (R-ME) and Tim Kaine (D-VA) stated S. 659 would “help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” Simmon stated S. 659 would “cut through patent thickets that delay biosimilars from coming to market.”

Traditionally, patent protection has given drug researchers incentives to pour millions of dollars and spend years of time developing new drugs.

Competition vs. Protection

It is not always easy to balance competition with patent rights, says Ed Hudgins, a senior fellow at The Heartland Institute, which publishes Health Care News.

“Much research, time, and money has been put into the biologics,” Hudgins said. “But biosimilars can rely on earlier tests of biologics to show safety or efficacy, riding on that earlier work without paying for it.”

Manufacturers of biosimilars have complained patent holders can “game” protection to shut out competitors. In September 2019, the Council published a paper, “Failure to Launch,” outlining alleged “anti-competitive” practices by brand-name manufacturers.

“Biologics certainly deserve protection, but the line can be unclear where the protection stops, allowing biosimilars to be developed,” Hudgins said. “One interesting thought is that the developers of biologics will ‘compete with themselves’ and develop biosimilars in-house before other companies do. The developers of biologics, of course, rely on the sale of those products to make back the costs of their R&D. But maybe they can develop a business model that will transition them from biologics to biosimilars, relying on sales volume to make up the difference.”

Physicians’ Time Crunch

Patent dilemmas notwithstanding, an online drug information database can be a positive development, especially for time-strapped physicians, Hudgins says.

“Unfortunately, our over-regulated health care system has seen huge increases in the number of administrators managing the system but only marginal growth in the number of physicians who actually treat patients,” Hudgins said.

Physicians have less time to keep up with medical advances, Hudgins says.  

“Biologics and biosimilars are on the cutting edge of medical advances, perhaps so cutting-edge that physicians and patients need to have their consciousness raised about the potential of these treatments,” Hudgins said. “Let’s hope biologics and biosimilars increasingly find their way into such information databases.”

Tackling Costs

An online database may be an excellent way around the patent dilemma in addressing the consumer costs for biologics, which can total tens of thousands of dollars per round of treatment.

Biologics face little competition. Only six biosimilars are available in the U.S market, and those face dispensing hurdles. For example, some states restrict pharmacists from swapping out a biologic with a biosimilar, and the FDA requires biosimilars to distinguish themselves by mandating the attachment of a suffix in their labeling.

Hudgins says the pricing hurdles can be worked out.

“Costs initially will determine the choice between biologics and biosimilars, but insurance companies also have an incentive to keep their policyholders healthy because, among other things, it means less costs to them,” Hudgins said. “There could also be insurance company choices between using biologics or biosimilars, which might be higher priced, vs. using more traditional treatments.”

One lesson could come from gene editing, now being tested to cure some forms of blindness, Hudgins says. 

“A treatment might be extremely costly in the short term but amortized over time and in light of the risks of reoccurrence of a condition or of treatment failures with more traditional, less-costly treatment, the more-costly treatment might be more cost-effective in the long term,” Hudgins said.

 A database on use of biosimilars and biologics could be important in overcoming cost problems, Hudgins says.

“Apart from the importance of educating patients and physicians about biosimilars, perhaps some dramatic results either in treatment results or lower costs would provide a breakthrough that would increase demand for and remove legal or other barriers to biosimilars,” Hudgins said.

Ashley Bateman ([email protected]writes from Alexandria, Virginia.