Tony Hagen is senior managing editor for The Center for Biosimilars®.
The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.
The biosimilars market in the United States is showing healthy vital signs, despite a slow start and anticompetitive practices that have driven manufacturers to global markets in search of profits, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the Biosimilar World Congress 2020 at the Festival of Biologics USA in San Diego, California.
Christl, who until a year ago was the FDA's associate director for Therapeutic Biologics and director of Therapeutic Biologics and biosimilar staff, also reassured the audience that the FDA is still keenly interested in furthering uptake of biosimilars.
“I think we are doing really well in the United States,” said Christl.
“Before the first biosimilar was approved , I think there were some misperceptions about what the US marketplace would look like. And I think there was an expectation that every product that was approved outside the United States was suddenly going to be this next-day submission to the FDA,” she said.
“What we saw was manufacturers that had ongoing development programs expand these programs into global development programs to include the US market,” she said, adding that markets abroad have looked more inviting to manufacturers because regulatory policies may be more favorable and anticompetitive practices may be less of an obstacle to recovery of invested capital.
Further products have been approved in the United States by different pathways, such as insulin and growth hormone hormones, said Christl, who at the FDA was responsible for developing policy on approvals and reviews for biologics and complex protein products. This is where the comparison becomes somewhat “apples to oranges,” she said.
Much excitement has been generated in the biosimilars industry over an upcoming worship workshop on overcoming anticompetitive practices sponsored by the FDA and the FTC. The March 9, 2020 event invites collaboration to support biosimilar adoption and discourage misleading statements about biosimilars.
The workshop will address the need to create public outreach to educate the marketplace about the role biosimilars can play, Christl noted.
“I’m happy to see that this meeting is in the works. It was something that was discussed in the FDA’s Biosimilar Action Plan— to have that partnership with the FTC and to really support the FDA’s educational and outreach program.”
The meeting will also help overcome misconceptions about the approvals process and the nature of biosimilars themselves, she said. “The marketplace in the United States is changing with product launches coming in. We’re starting to see competition, so it’s really necessary and timely to have that framework.”
Manufacturers are “engaging” with the marketplace, she said. “There is obvious interest in moving forward. There are biosimilar development programs and new reference products, and I don’t think that’s going to wane.”
There has been debate over whether the FDA’s standards for biosimilar approvals are scientifically appropriate, so ticking off the boxes on the FDA’s license application form constitutes an added challenge. Biosimilars remain highly complex products with multiple mechanisms of action and so it is necessary to gather volumes of data to cover the bases necessary to establish whether biosimilars do pass the test, Christl said.
The debate over lowering standards is not something that should preoccupy regulators, she said. “I think any time anyone talks about lowering standards, I like to think that altruistically the conversation is really around making sure we have the right standards and what is scientifically appropriate to demonstrate biosimilarity. Patients should never hear regulators talk about lowering the standards. Patients are going to use biosimilars and they need to know that these products are safe and effective, and standards should support that, period.”
At the time of Christl’s departure from the FDA there were other key vacancies developing at the FDA. Scott Gottlieb, MD, was the commissioner and left in early May 2019. Heads of science and policy groups also departed for other positions around that time, and those positions have been filled internally with dedicated staff, Christl said. Her statement came in response to an audience member’s question of whether there are still “champions” for biosimilars at the FDA.
The new section heads can be counted on to do their part, she said. “I know that they were very passionate about [biosimilars] and I know they will take up that mantle.”
“We’ve seen some conversations with the new commissioner [Stephen M. Hahn, MD] about biosimilars regarding policies coming out of the FDA on draft guidances and other engagements. I’m hopeful the newcomer [Hahn] will also take on that role, but I think that we as stakeholders need to keep pushing as well, and remind them that we do need those champions and they do have such a large role to play in how things go in the US and that they need to be engaged,” she concluded.