Sheila Frame, US head of Marketing and Market Access and Patient Services for Sandoz, discusses her company’s growing portfolio, the pipeline of biosimilar drugs, and the need for a more robust biosimilars market in the United States.
The United States is on the verge of becoming a leading market for biosimilars despite being 10 to 12 years behind Europe, said Sheila Frame, US head of Marketing and Market Access and Patient Services for Sandoz, in an interview with The Center for Biosimilars®. Frame spoke at the World Biosimilar Congress 2020 at the Festival of Biologics USA, March 2-4, 2020, in San Diego, California.
“Finally, people are realizing that the current healthcare system in the United States is not sustainable,” Frame said. “Biosimilars offer such an obvious opportunity for immediate savings. This not only will help save the system, but also improve access and certainly improve patient care.”
Frame said she has been told she is too optimistic about the US market for biosimilars, but she has kept a positive state of mind due to an improving policy environment and an increased focus on education for patients and physicians.
Looking at the experiences of Europe and Canada, where biosimilars are better established, it is clear that incentives in the healthcare system boost physician and patient adoption of biosimilars much more quickly, she said.
She suggested that incentivizing physicians to prescribe more biosimilars, incentivizing patients to use them by offering $0 copays, and using the Medicare Star Rating System to prompt payers to increase biosimilar uptake all hold strong potential to improve biosimilar access for patients.
“We continue to move policies forward that will enable biosimilars, in terms of uptake in the space, and we're very hopeful that we will be the first in the United States to bring a pharmacy benefit Part D medication to the market later this year,” Frame said about Sandoz’ prospects.
Sandoz has 8 biosimilar products on the market. Their most recent launch, Ziextenxo, is a long-acting pegfilgrastim product. Sandoz is the only drug manufacturer in the United States to have both a short- and long-acting filgrastim product.
Currently, there are multiple bills in Congress intended to encourage biosimilar uptake. Frame said that unlike many other types of legislation, biosimilars initiatives tend to have bipartisan support.
Regarding patent expirations, Frame noted that several originator ophthalmic and diabetic medications will be losing their exclusivity in the next 5 to 7 years, creating opportunities for the biosimilar market.
She also spoke about the importance of biologic immunology drugs and Sandoz’ mission to create more biologics in that space. “We know from an oncology perspective that the immunotherapies have completely revolutionized the treatment of cancer, and in fact, many people now will die with cancer, not from cancer.”
A March 9 workshop involving the Federal Trade Commission, the FDA, and industry advocates and stakeholders was held to address needed investigations into barriers to US biosimilar uptake and how to speed it up. Frame described the meeting as an important step forward.
“At the end of the day, what we really need to do is take advantage of the savings that are available to American patients and to the system overall. It seems right now like it's unsustainable [for the United States] to have the highest percentage of [gross domestive product] in the world invested in healthcare, and yet, our life expectancy continues to decline,” Frame said.
“The opportunities that biosimilars can provide to patients, to providers, and to the system overall, are significant, and in the United States right now, it's obvious it's an easy solution that could be implemented quite quickly,” she added.