Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.
“The effect of the pandemic has essentially put the biosimilar market on hold,” said Joseph P. Fuhr Jr, PhD, MA, a professor emeritus of economics at Widener University and an advisory board member of The Center for Biosimilars®. Fuhr joined other board members who discussed the state of the biosimilars market and what to expect in 2021. “Hopefully the coming year will lead to more advancement in competition in biosimilars,” he said.
The year 2020 saw just 3 biosimilar approvals from the FDA, which brings the total to 29 since the first US biosimilar approval in 2015. “Although 2020 brought many fewer FDA biosimilar approvals (most recently, the rituximab Riabni), the pandemic has created additional financial pressures for providers, and of course patients, which has resulted in heightened attention to biosimilars as potential cost savings opportunities,” said Advisory Board Member Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars for Cardinal Health.
Indeed, many companies across the globe saw significant value in biosimilars in 2020 and have pushed forward with clinical trials, factory construction, and partnerships with other companies to establish a market presence wherever markets for biologics are robust.
Pandemic Hasn't Slowed Biosimilars
“It is a positive that we have continued to see uptake of biosimilars, even with the pandemic continuing,” said Advisory Board Member Steven Lucio, PharmD, BCPS, senior principal for the Center for Pharmacy Practice Excellence at Vizient. “Through the third and fourth quarter, we saw substantial growth in market share for biosimilars, particularly in the oncology monoclonal antibody space where additional competing products were approved and launched.”
Advisory Board Member Sarfaraz K. Niazi, PhD, an adjunct professor of pharmaceutical science at the University of Illinois, described the slow pace of new biosimilar approvals in 2020 as disappointing, noting the sharp upward trend in previous years: 10 approvals in 2019, 7 in 2018, and 5 in 2017, and 2 in 2016. “More disappointing was the observation that no new molecule joined the list of previous molecules: filgrastim, rituximab, pegfilgrastim, adalimumab, trastuzumab, infliximab, etanercept, bevacizumab, and epoetin alfa. The European Medicines Agency had more activity, approving 9 products, including pegfilgrastim, bevacizumab (2), trastuzumab, insulin aspart, etanercept, rituximab, and adalimumab. Again, no new molecules were in the authorized category of the European Medicines Agency either,” Niazi said.
The year was significant on the regulatory level for biosimilar diversity, he said, because on March 23—the 10-year anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which created the pathway for biosimilar approvals—insulins and various other biologics were added to the drug categories that could be approved by this means. These may include treatments for respiratory distress syndrome, fertility conditions, Cushing syndrome, deep vein thrombosis, Gaucher disease, and many more. Niazi said this increases the likelihood that an interchangeable biosimilar may soon be approved, which would allow automatic substitution with brand prescriptions at the pharmacy counter. “As of today, no biosimilar insulin has been approved by the FDA, but I foresee many coming soon.”
Lucio echoed the concern that the number of biologics for which biosimilars exist in the United States is limited to 9. “It is great to have additional competition for the same molecules. However, it would be even better if the number of biologics for which biosimilar competition exists would grow. Whether this takes the form of true biosimilars for insulins or competition for a biologic like ranibizumab, we need to move beyond the 9 biologic targets currently approved,” he said.
Real Value to "Interchangeable"?
Lucio also said that while an “interchangeable” designation is a much-talked-about objective, it has yet to be demonstrated that such an appellation for a biosimilar will make a difference for patient access and cost reduction. “It would be interesting to see if someone breaks through the interchangeability hurdle so we can truly discern the relevance of this designation.”
The year 2020 witnessed a challenge to the Affordable Care Act (ACA) that put one of its constituent elements, the BPCIA, in jeopardy. Many observers believe the individual mandate will be found severable from the ACA, and therefore the rest of the statute will remain empowered, but the outcome is not 100% certain as long as the issue is deliberated by the Supreme Court. “I hope that the most recent challenge to the ACA does not negatively impact the 351(k) pathway so we can move beyond this existential threat to biosimilar licensing for good,” Lucio said.
Advisory Board Member Ha Kung Wong, an intellectual property attorney and partner with Venable, said the loss of the BPCIA via the ACA review would be devastating for the stability of the biosimilar approval structure. “We’ve had concerns that if the BPCIA were to disappear, legal and regulatory frameworks for biosimilars would need to be recreated, which could cause lots of issues with respect to already approved abbreviated Biologics License Applications (aBLAs), pending aBLAs, and biosimilar litigation, which could significantly impact patient access,” he said. “Our current read on the oral arguments is that the Supreme Court will do what we expected and remove the individual mandate while severing the remainder of the ACA and thus sparing the BPCIA.”
The combination of the pandemic and general preference for innovator biologics, for whatever reasons, amounts to lost savings for the health care community and patients in particular, said Advisory Board Member Brian Lehman, MBA, MHA, RPh, director of Strategic Alliances and Patient Advocacy at Sandoz. “Based on the most recent prices for the 9 biologic drug classes with FDA approved biosimilars, as of December 2020, estimated patient out-of-pocket, lost savings is greater than $270 million and increasing day-by-day. Similarly, between 2018 and 2020 the estimated year-to-date lost savings to the health care system is greater than $24 billion.”
Not only is the near-term savings potential from biosimilars huge, but also “an estimated 1.2 million US patients could gain access to biologics by 2025 as the result of increasing biosimiar availability,” Lehman said. This is based on an estimated $100 billion in potential savings for the 5-year period ending in 2024, he said.
Potential savings from biosimilars for all self-insured US employers could have reached $1.4 billion in 2018 had they made sufficient use of biosimilars, according to an ERISA Industry Committee study Lehman cited. But employers are moving in this direction. “I anticipate the adoption of more biosimilars will have a positive impact for the industry going forward. The more we see employer-sponsored health plans include biosimilars, the more we can expect to see cost savings for employers and employees alike, as well as increased medicine access for patients, resulting in healthier and more productive employees.”