Molly Burich, head of public policy for Boehringer Ingelheim, a global drugmaker, discusses hopeful signs that the biosimilar market in the United States is improving.
In theory, a patient who shows up at the pharmacy could get a biosimilar instead of an original brand product, and thereby save money, but only if that biosimilar has an interchangeable designation.
This would translate into savings for the patient and the healthcare system, but we don’t have any biosimilars so far that are designated interchangeable, notes Molly Burich, head of public policy at the pharmaceutical company Boehringer Ingelheim.
That’s because all 17 biosimilars that are on the market are administered by physicians as intravenous products, not as orals distributed at the pharmacy counter.
“The reason why we don't have any interchangeable biosimilars yet is because all that have launched are on the medical benefit side, and without that pharmacy interplay there's really no need to have an interchangeability designation,” said Burich, who talked about biosimilar acceptance at the recent World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.
Now, with insulins and growth hormones added to the list of products that can be approved through updated the regulatory pathway for biologics, the day will come when the interchangeable designation does apply to some biosimilars.
“Interchangeability in the United States is unique in that other countries that have biosimilar competition don’t have that standalone designation, but we do in the United States,” Burich said. That automatic substitutability for pharmacy benefit biosimilars will provide substantial value, she said.
FDA Makes it Easier to Understand Insulin Pathway
Recently, the FDA provided fresh guidance for drug manufacturers to simplify the development of interchangeable biosimilar insulins. The guidance clarified what information may or may not be needed to demonstrate biosimilarity and interchangeability for proposed insulin products.
The recommendations in the draft guidance “may result in a more efficient development program that could ultimately bring biosimilar or interchangeable insulin products to the market more quickly,” the FDA said.
Burich said that Boehinger Ingelheim supports the new guidance and feels FDA should use interchangeability on a product-by-product basis. “We want to make sure that the interchangeability designation is in fact meaningful, that it is generating a complement of data around patient switching that will help drive physician confidence and patient acceptance as well,” said Burich.
How Administrators and Payers Could Smooth the Way
Burich also discussed other barriers to biosimilar uptake, such as payment systems that tend to favor costly original brand products. She suggested that efforts at the federal and payer levels need to be taken to allow for “misaligned incentives” to be removed or adjusted to benefit biosimilars.
An example of federal action that could improve uptake is the implementation of shared savings models, which allow physicians and patients to share the savings generated by using more affordable products. Burich feels the current administration has the ability and authority to do that now.
There has also been congressional interest in improving the average sales price payment for physicians, reducing out-of-pocket costs for patients, and applying star ratings to Medicare plans to grade them on quality and performance. “All of those things are really important to help get the market moving and stimulate the biosimilar market so that we not only have better uptake now, but we have a long-term, robust, and sustainable market where we’re truly driving down costs,” she said.
“From a patient standpoint, we need patients to have confidence in the market, but also see a true benefit to their out-of-pocket costs,” she said.
Numerous bills have been introduced in Congress to support the biosimilar market, many of which have bipartisan support, Burich noted.
“So, I think the energy and excitement on Capitol Hill and support for biosimilars is there. We would love to see some of these bills come to fruition. We remain hopeful that Congress is truly looking toward biosimilars as part of the solution to lower drug costs in the United States.”
For more background on recent efforts to promote interchangeability, read this column by George C. Yu, JD, and Christopher Bruno, JD.