FDA's Leah Christl Takes to Reddit to Explain Biosimilars

On Thursday, Leah Christl, PhD, director of the therapeutic biologics and biosimilars staff at the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs at the FDA, hosted the organization’s first “Ask Me Anything” session about biosimilars on the website Reddit. Christl responded to user questions about the biosimilar approval process, the differences between a biosimilar and an interchangeable product, and pricing.

Though the FDA has released many educational items and guidance documents around various topics that were addressed throughout the AMA, user questions pointed to lingering confusion about biosimilars across stakeholder groups, as evidenced in queries about whether adverse events related to biosimilars can be expected to be the same as those associated with a branded product.

When asked if there have been any instances of new adverse events resulting from a biosimilar that were not seen with a branded reference, Christl first reiterated that, during the biosimilar approval process, the manufacturer must demonstrate that the proposed biosimilar has no clinically meaningful differences from the reference.

“All drugs have risks and benefits. Biosimilars can have side effects, which are expected to be the same as those of the reference product the biosimilar was compared to,” she said.

Christl also commented that the difference between a biosimilar and an interchangeable product is a question that she and other members of the FDA receive often.

“An interchangeable product, in addition to meeting the standards as a biosimilar, meets additional requirement. A manufacturer of a proposed interchangeable product will need to provide additional information to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient,” said Christl. She added that, for a product that is administered to a patient more than 1 time, a manufacturer will need to provide data and information to evaluate the risk of alternating or switching between the product and its reference, and reiterated that pharmacy-level substitution of interchangeable products will be guided by state law.

When asked what can be done about pharmaceutical companies rebating brand-name biologics to forestall biosimilar competition, Christl explained that, though the FDA does not regulate drug prices, it is charged by Congress to approve policies that maintain a balance between encouraging medical innovation and facilitating robust market competition.

“As Commissioner Gottlieb has stated, most recently during his speech at America’s Health Insurance Plans’ National Health Policy Conference, it is FDA’s view that current rebating and contracting practices can reduce the incentives for sponsors to invest in the development of biosimilars. That is why the FDA is looking into additional steps the agency can consider to encourage biosimilar competition, while continuing to maintain strong incentives for innovation,” said Christl.

In closing, Christl noted that the FDA is examining its biosimilar program to better integrate both policy and review functions that can provide greater clarity for sponsors as well as greater efficiency in the review of biosimilar and interchangeable applications. The FDA “hopes to have more to say on this soon,” she said.

As of April 1, 2018, 63 programs were enrolled in the FDA’s Biosimilar Product Development Program, and CDER has received meeting requests to discuss the biosimilar development for 31 different products.