Biosimilar uptake stunted despite greater competition, lower costs
CHICAGO — The availability of biosimilars introduces market competition that reduces the cost of drugs, even in situations where the actual cost of the biosimilar is higher than that of its reference product, according to Jonathan Kay, MD, of the University of Massachusetts Medical School.
Speaking before attendees at the 2019 Interdisciplinary Autoimmune Summit, Kay added that even if a biosimilar has a higher cost than its reference drug — after discounts and rebates — its mere presence in the market still introduces competition that results in “effective treatment for patients with the reference product at a lower cost.”
“The availability of biosimilars should decrease the cost of treating patients,” Kay said. “Lower-priced biosimilars introduce market competition, which provokes discounts and rebates for bio-originators. Multiple biosimilars of the same reference product drive price down. Biosimilars should be more readily available to patients for whom the bio-originator has been inaccessible, and greater global access to effective biopharmaceuticals should reduce disability, morbidity and mortality associated with inflammatory diseases.”
However, the use of biosimilars across the globe has been uneven, with limited uptake seen in the United States compared with European countries like Norway, according to Kay.
In Norway, the biosimilar Remsima (infliximab-dyyb, Celltrion) saw a 39% price reduction in 2014 compared with its reference product, Remicade (Janssen). In 2015, the same year it secured the Norwegian national hospital tender bidding process for biologics, Remsima announced a 69% price reduction compared with Remicade.
The use of Remsima surpassed that of Remicade for the first time in March of that year, according to Kay. Since then, use of the biosimilar has increased, while prescriptions for the reference product has fallen.
In Sweden, economic forecasters have predicted that sales of Amgen’s adalimumab biosimilar, Amjevita, would approach 140 million by 2022. In response, AbbVie, which produces the originator Humira, reduced its price by 80%, thereby winning the Swedish national tender for adalimumab.
According to Kay, biosimilars for the drug were available in Nordic countries at a 10% to 80% discount.
“AbbVie was prompted to lower their price because of biosimilar competition, so patients benefit regardless of whether they get a biosimilar or reference product,” he said. “Either way, they are getting an effective treatment at a lower price.”
In the United States, however, uptake of the Remicade biosimilar, Inflectra (infliximab-dyyb, Celltrion) has been slow. According to Kay, sales of Inflectra have paled in comparison with Remicade, which totaled $1.06 billion during the second quarter of 2017, against the $23 million earned by the biosimilar during the same period. So far this year, Remicade has reported more than $2 billion in sales.
This slow start for the biosimilar is partly due to the fact that, in early 2017, the average selling price for 100 mg of Inflectra was about $200 more than that of the reference product, after rebates and discounts, Kay said. This changed in the third quarter of 2017, when the average selling price for 100 mg of Inflectra dropped to $802, compared with $857 for Remicade. Since then, the price for both products have fallen to the current price points of $543 for 100 mg of Inflectra and $718 for the same amount of Remicade.
“That is almost a 50% decrease in the cost of Inflectra,” Kay said. “So, you can see the effects of price competition.”
According to Kay, other reasons for the slow uptake of biosimilars in the United States include a relatively slow regulatory process, patent litigation issued by bio-originator companies, pharmacy benefit managers giving preferred formulary status to reference products and a lack of any systematic efforts to educate skeptical physicians and patients.
“It is safe, effective and cost-effective — in most countries — to switch to a biosimilar,” Kay said. “The availability of biosimilars means market competition that results in effective treatment for patients at a lower cost.”– by Jason Laday
Kay J. Optimizing biosimilars for safe and effective management of IMIDs. Presented at: Interdisciplinary Autoimmune Summit; April 5-7, 2019; Chicago.
Disclosure: Kay reports research grants from Pfizer and UCB, as well as consulting fees from AbbVie, Boehringer Ingelheim GmbH, Celltrion Healthcare, Merck Sharp & Dohme, Pfizer, Samsung Bioepis, Sandoz and UCB.