Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
By Jacquie Lee
The Food and Drug Administration in the next few weeks will unveil a program to streamline approvals for complex drugs—commonly referred to as biosimilars—in an attempt to stem skyrocketing drug prices and improve drug accessibility for patients.
Scott Gottlieb, head of the agency, hit on all the industry buzzwords in his address to a crowd of food and drug policy wonks at a Food and Drug Law Institute conference May 2. Drug prices are out of hand and policy loopholes are being utilized by drug companies for the wrong reasons, Gottlieb said in his speech.
The agency has already ramped up its approval rates for generic drugs. Now, it will take a closer look at streamlining the approval process for biosimilars, which are complex drugs that are highly similar to and can be substituted for a biologic drug already on the market. The plan, which will attempt to increase competition between drug manufacturers and increase the number of biosimilars on the market, will be announced within the month, an FDA representative told Bloomberg Law.
“The commissioner believes the market would benefit from additional products on the market,” the representative said. But issues within the biosimilar market are unique—payers and branded manufacturers are “colluding to keep the biosimilars market from developing,” said the representative, who asked not to be named. That adds a layer of complexity to the way the FDA regulates those drugs.
One way to crack down on that collusion is to make it easier to establish equivalence for biosimilars so there are more of them available. “More options put more pressure on insurers and pharmacy benefit managers to put the biosimilars on the formulary,” which is a list of prescription drugs covered by a prescription drug plan, the representative said. The limited number of biosimilars now makes it easy to keep them off that list.
But a better biosimilar plan would require the FDA to have “a more sophisticated” understanding of the two “levels” of biosimilars, Peter Pitts, president of the Center for Medicine in the Public Interest, told Bloomberg Law.
All biosimilars approved in the U.S. are technically “level one,” which means there are very few differences in the molecular makeup of the biosimilar and its established counterpart. “Level two” biosimilars don’t exist in the U.S. Those are complex drugs that have the same effect in clinical trials as the original drug the biosimilar is copying.
“A step forward is to understand the pathways to biological interchangeability,” Pitt said, referring to the term used to describe two formulas a patient can switch between without problems. But the different “levels” within the science behind biosimilar drugs is complicated, and the FDA has had a hard time keeping up, he said.
Biosimilars are also more expensive, and creating a biosimilar doesn’t lower the price of the drug as much as creating a generic version of a drug does. When a generic version of a brand-name drug comes out, the price of the drug goes down about 80 percent, Pitt said. For biosimilars, that list price goes down about 30 percent.
Biosimilars are more complex and more prone to cause adverse reactions, so they require large clinical trials to be approved by the FDA. Their complexity is what makes them significantly more expensive to develop than generic drugs. In a March speech, Gottlieb estimated biosimilars take about $100 million to $250 million to develop versus the roughly $10 million it would take to develop a generic version of a drug.
“For our system to continue to work, innovation has to be balanced with competition and access,” Gottlieb said.
To contact the reporter on this story: Jacquie Lee in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at email@example.com
Copyright © 2018 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)