In the US, the first biosimilar was launched in September 2015. As of this writing, there are 38 FDA-approved biosimilars; 22 of them are commercially available. These 22 products compete in nine classes of molecules across oncology, rheumatology, diabetes care and now ophthalmology. According to the most recent “Report on Generic and Biosimilar Medicines Savings in the United States” from the Association for Accessible Medicines, biosimilar savings in the United States were $ 7.9 billion in 2020 (three times the savings in 2019 ) and could increase to $ 133 billion by 2020. 2025.
Biosimilars for oncology have been among the most often cited success stories. Nearly 80% of biosimilars launched in the United States have indications for oncology, and market adoption has been strong in both therapeutic and support products. Biosimilars for Avastin (common name bevacizumab, used to treat various cancers) come close to 80% of the market share; biosimilars for Rituxan (common name rituximab, used to treat certain cancers and autoimmune diseases) have exceeded 70% market share; and biosimilars for Neupogen (non-proprietary name filgrastim, often used in conjunction with many cancer treatments to stimulate the growth of white blood cells to fight infections) have started to stabilize in the low 90% range.
More impressive than the adoption rates is the rate of adoption of many biosimilar products. Although biosimilars for bevacizumab, trastuzumab, and rituximab are only commercially available from mid to late 2019, the rapid acceptance and adoption of these cancer biosimilars is often seen as the key driver of biosimilar savings in the US market.
In contrast, the market share of Remicade biosimilars (non-proprietary name infliximab, used to treat many autoimmune diseases including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriasis plaques) just surpassed 40% in the last quarter, even though the launch of the first Remicade biosimilar took place in July 2016.
Is this seemingly less than robust biosimilar competition against Remicade a failure? I say “No,” based on my analysis of data from the Centers for Medicare and Medicaid Services on beneficiaries’ spending on Part B drugs – drugs given in doctor’s offices and other outpatient settings by doctors and other health care providers – dating back to 2012 The table below shows the total expenditure in the infliximab category from 2015 to 2020:
Although it took about two years for Remicade biosimilars to be used in Part B, the impact on the cost curve was rather surprising. In the past three years, total spending for the infliximab category has dropped 42% from its 2017 peak. Despite more than $ 300 million in new infliximab biosimilar spending between 2018 and 2020, total spending in the category has plummeted. How come? A significant part of the decline comes directly from falling prices for the branded reference product, Remicade. In fact, Remicade’s sales in Medicare Part B fell by $ 678 million (51%) between 2017 and 2020.
Rheumatology, unlike oncology and other therapeutic areas, saw stiff price competition between biosimilars and the benchmark product, Remicade, which resulted in significantly lower costs for the entire class. Average selling prices of infliximab products show that Remicade’s has declined 58% since 2018, moving hand in hand with its biosimilar competitors quarter after quarter.
In response to stiff price competition, Remicade maker Janssen Biotech recently launched an unbranded version of Remicade called Infliximab which offers an incredible nearly 60% discount off the list price, formally known as the cost of acquisition at the retailer. wholesale. This unbranded version now has a lower list price than Remicade’s original 1998 average wholesale price.
In my analysis, it is unlikely that the price erosion of the Remicade brand, represented by the average selling price, and the launch of an unbranded version of Infliximab at a discount of around 60%, would have occurred without the launch of a biosimilar competition.
The Biologics Price Competition and Innovation Act, which was converted into law as part of the broader Affordable Care Act in 2010, had the ultimate goal of creating a path for manufacturers to develop and launch organic products to compete with reference products. after their loss of exclusivity. Biosimilars were designed to help reduce the costs of high-priced biological products and also to further stimulate innovation in the next generation of therapies, hence the inclusion of the word “innovation” in the name of the act.
In oncology, biosimilars have enabled significant cost savings by obtaining a high market share for modest price reductions. In rheumatology, Remicade’s biosimilars have prompted the manufacturer to fiercely defend its market share and drastically lower prices, making biosimilars a key factor in stimulating competition, lowering prices and increasing patient access to treatments that change your life.
While biosimilars in rheumatology still don’t account for half the market share, they haven’t failed. On the contrary, I believe they have been a huge success.
Looking ahead, market sustainability is a topic that deserves more attention, particularly for infliximab products. As average selling prices continue their aggressive downward trend, so too do supplier reimbursements under the purchasing and billing model, in which suppliers purchase drugs to administer to their patients and then bill patient insurance to recover the cost of the medicine. The economic benefit for a provider in this model is the margin between the cost of the medicine they buy and the value of the reimbursement they receive from the patient’s insurance.
The reimbursement is determined by the average selling prices of a product. If it falls faster than the supplier’s cost of purchasing the medicine, the supplier’s economy is likely to turn negative – purchase cost higher than reimbursement – and could create significant disincentives to convert to biosimilar products with lower average selling prices. This perilous cat-and-mouse game may ultimately require new policies or economic models to change the dynamic and is worth analyzing further to ensure a robust and competitive biosimilar market that is sustainable in the long term.
Jeff Baldetti is the director of biosimilars at Cardinal Health, a global health services company and distributor that provides access to distribution and solutions for a wide range of pharmaceutical products, including biosimilars.