Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.
Amgen released its ninth edition of its Biosimilar Trends Report, giving an extensive look at the current state of the market for biosimilars, which the company says has driven $21 billion in savings over the past 6 years.
Since 2015, 39 biosimilars have been approved by the FDA and 24 have launched. Overall, the average sales price (ASP) of reference products and biosimilars is dropping. The prices have gone down at a negative compound annual growth rate of -9% to -24% for biosimilars and -4% to -21% for originators. In addition, biosimilars have an average of 75% market share if they launched during 2019 and 39% share during the first 3 years if they launched before 2019.
The report predicted a greater expansion of biosimilars in the pharmacy benefit space, biosimilars in more therapeutic classes, and more approvals and launches for interchangeable biosimilars. Additionally, the report noted some of the biggest regulatory policies that have impacted biosimilars in 2022, including the passage of the Advancing Education on Biosimilars Act, the reauthorization of the Biosimilar User Fee Act for 2023-2027, and the Inflation Reduction Act.
“We anticipate biosimilars in 2022 to continue the promise of cost savings to have the potential to increase access to patients. This year will prove pivotal for the pharmacy benefit space, as providers and pharmacists navigate the first interchangeable biosimilar insulin listed as preferred on several national formularies,” said Beth McMahon, senior vice president of emerging therapies and channel strategy at AmerisourceBergen, in the report.
In addition to more legislation and more biosimilars, the number of development programs that are participating in the FDA’s Biosimilar Development Program has risen from 77 programs in March 2019 to 96 programs in March 2022, despite a slow increase in 2020 as a result of the COVID-19 pandemic.
Biosimilars in the medical benefit typically launched at a wholesale acquisition cost (WAC) that is between 10% and 57% lower than the WAC of the originator.
The report noted the successful uptake of oncology biosimilars, which account for nearly 80% market share in the trastuzumab and bevacizumab markets and 64% of the rituximab market share. Despite biologics representing half of the therapies used in treating cancer, the high cost associated with them results in much greater costs in development and production compared to small molecule drugs.
“The price takes its own toll on cancer patients with [more] patients facing out-of-pocket costs. It becomes hard for them to sustain the level of cancer care. I think biosimilars definitely help assimilate some of that kind of challenge,” said Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care.
Trastuzumab biosimilars have led to a 19% price drop in the reference product (Herceptin) and bevacizumab biosimilars have resulted in a 15% decline in Avastin’s (reference bevacizumab) price. Rituximab biosimilars have led to an 11% drop in the ASP of Rituxan (reference rituximab) and are priced between 51% and 56% lower than the reference product.
Additionally, biosimilars account for 42% of the pegfilgrastim market and generated $724 million in savings by the second quarter of 2022 (Q2 2022). Filgrastim biosimilars are also priced between 60% and 81% lower than the reference product (Neupogen) and account for 82% of all filgrastim products.
The presence of 1 epoetin alfa biosimilar has resulted in significant price declines for the biosimilar and the reference product (Epogen/Procrit), both experiencing over a 30% decrease from the ASP of the reference product in the fourth quarter of 2018, when the biosimilar launched.
Infliximab biosimilars have experienced a tougher adoption journey. Although the ASP of the originator Remicade has dropped 57% since the onset of biosimilar competition, infliximab biosimilars still trail behind the reference product in market share (42% vs 54%, respectively). However, infliximab biosimilars have still resulted in $660 million in savings in Q2 2022.