Navigating Biosimilar Lifecycles: Key Considerations for Sustainable Cost Savings

Fifty biosimilar products have been approved by the FDA across 15 unique biological molecules, explained Chrys Kokino, president, Accord US, during Asembia's AXS24 Summit in Las Vegas. According to Kokino, reaching this number of FDA-approved products in the United States is a significant step for the field of biosimilars.

“This is a major milestone. In fact, in the last week or so there were 2 recent approvals,” Kokino said. “One was for a trastuzamab [Herceptin; Genentech] molecule that happens to be with a company I represent. Then ALVOTECH also had an approval for their ustekinumab [Stelara; Janssen Biotech, Inc] molecule. So, there's tremendous effort being made in terms of getting these products approved so that ultimately we can launch them into the US marketplace.”

Kokino noted that oncology is an area that has seen significant growth in terms of biosimilar product development. For the biosimilars that have been approved in oncology, Kokino explained that products have not only fallen into what he termed “primary oncology,” which includes products such as trastuzamab and bevacizumab (Avastin; Genentech), but also into supportive cancer care products, such as pegfilgrastim (Neulasta; Amgen).

Image Credit: © ipopba - stock.adobe.com

“It's no secret that oncologists are the most familiar with biosimilars,” Kokino said. “Back in 2009, when I was living in Europe and launched [biosimilar] products across Europe, as well as the Middle East, Latin America, and Japan, the first target audience we went after were oncologists, so it's no surprise that there's this many products that are within the therapeutic area of oncology and, of course, supportive care.”

According to Kokino, the new entrants in the biosimilar marketplace are the immunology products. “There's this tremendous effort to continue to commercialize and launch products in various therapeutic areas besides the 50 molecules [currently approved], so we can continue to displace some of the reference products,” Kokino said.

Additionally, Kokino noted that manufacturers have come to believe that biosimilars have approximately a 3-year lifecycle, which is based on the course of the evolution of biosimilars from 2009 to the present. According to Kokino, this has to do with new competitors coming into the marketplace, as well as pricing. Specifically, pricing of biosimilars is impacted by what Medicare Part B generally pays for biosimilar products, which is calculated using the average sales price (ASP) of the reference biologic product plus 6%.

“So, there’s a consistent decline in price over time. Over the course of 3 years, you pretty much know what kind of revenue you'll be driving and what kind of penetration you're going to get [with a biosimilar product],” Kokino said. “When it comes to market shares, the top 2 products that have what I would call ‘fast uptake,’ such as the bevacizumab and trastuzamab biosimilars, achieved about a 75% market share. In contrast, though, the pegfilgrastim and epoetin alfa [Procrit, Epogen; Amgen] biosimilars have had a slow uptake.”

Kokino explained that when looking at these data, questions arise regarding why certain biosimilars have such a fast uptake while others have an uptake that remains quite slow.

“Is it because of the pricing? Is it because that was the audience that was most familiar with these products? Is it because there were healthy rebates that were given to some of those that were coming to the products? Is it because, for some of these products, physicians woke up to the fact that they could make a little extra money by utilizing another revenue stream for their practices?” Kokino said.

For manufacturers, these questions are critical because they help manufacturers determine which biosimilar products they will continue to develop when looking at 3-year timeframes for the biosimilar lifecycle, and which ones they will not. Notably, for the fast uptake products, such as the bevacizumab and trastuzamab biosimilars, a 70% decline in ASP has been noted since their launch, according to Kokino.

“So as a biosimilars manufacturer, we look at these kinds of trends and ask ourselves, ‘What really is the lifespan of these products,’” Kokino said. “We used to say the cost of developing biosimilars was anywhere from $50 million to $350 million, with the majority of the cost attributed to clinical trials. But there's a clear direct correlation between those products that have a fast start, and, of course, a reciprocal decline in ASP over time.”

However, use of biosimilars in US health care has the potential to provide immense cost savings over time, according to Kokino. There are multiple market research organizations that are studying what the potential cost savings will be, with one organization estimating there could be $100 billion in savings in the United States alone by 2028. Another research firm in Europe estimated there could be a savings of 70 billion euros globally by 2029, Kokino explained.

“What is the right number? I don't know,” Kokino said. “But what I will tell you is that, unless we start to see the sustainability of this industry, these numbers will decline significantly.”

REFERENCE

Kokino C. Leadership and Adapting to a Changing Biosimilar Industry. AXS24 Summit; Las Vegas, NV; April 28-May 2.