Although the US biosimilar market had a slow start, the booming industry in Europe shows the potential for the market here. However, in order to level the playing field, more policy changes and legislation are needed to prevent originator products from crowding out competitors.
Sean McGowan, senior director of Biosimilars at AmerisourceBergen, is confident that 2020 will be a big year for the biosimilar market with the addition of 6 new biosimilar products launching within a 3-month timeframe, as discussed in a recent podcast with The Center for Biosimilars®.
Two trastuzmab biosimilars, Trazimera and Ogivri; 2 rituximabs biosimilars, Truxima and Ruxience; a pegfilgrastim biosimilar (Ziextenzo); and a bevacizumab biosimilar (Zirabiv), all have become commercially available since early November. Trazimera entered the market this week, becoming Pfizer's third biosimilar after Truxima and Zirabev.
McGowan sees this as a sign of increased choice and access for providers, customers, and patients, as well as an opportunity for increased competition. “The broader market is expecting this increased competition,” he said, adding this “will help to create serious potential for the pricing of these products to come down, which really leads into the whole value proposition of the biosimilar platform.”
­Although the US biosimilar market had a slow start, the booming industry in Europe shows the potential of for the market here. However, in order to level the playing field, more policy changes and legislation are needed to prevent originator products from crowding out competitors.
In addition, McGowan said, different entities across the healthcare spectrum—including wholesale partners, manufacturers, downstream customers, and state and federal legislators—must work together to better “understand what the value proposition is for these products.”
A major example of this issue is AbbVie creating an aggressive patent thicket to keep the psoriasis drug, adalimumab (Humira), from having biosimilar competitors enter the US market. “The payer community needs to start adopting biosimilars at a much faster rate, not disadvantaging biosimilars,” McGowan urged.
The emerging insulin biologic market is one that McGowan says he will be watching closely. On March 23, 2020, a new provision will go into effect under the Biologic Price Competition and Innovation Act of 2009 (BPCIA), changing the approval pathway for biologic insulin which McGowan described as “an exciting new development.”
McGowan also noted tht Pfizer’s biosimilar launches—Zirabev (referencing Avastin), Ruxience (referencing Rituxan), and Trazimera (referencing Herceptin)—would reach the market within a span of 2 months.
This is huge for the market of products referencing Herceptin, which only had 2 biosimilars on the market last year, including Ogivri. “Now all of a sudden, we'll have 3 and by the looks of it by the end of 2020, the Herceptin market could have up to 5 biosimilar products,” McGowan said.
McGowan’s biggest advice for increasing competition is to bridge the knowledge gap for biosimilars. Although manufacturers do a great job of discussing the value proposition biosimilars bring, there needs to be a continued effort to expand knowledge around what manufacturers are doing, how much time and resources are being invested, how to better understand the pathways to FDA approval, and what the data shows about the efficacy and safety of biosimilar products.
As the market grows and expands, McGowan wants to see an increased understanding of what the real savings are in the marketplace not only for large entities but also for specialty practices, including those in oncology and rheumatology.
“It’s really incumbent upon the manufacturers, wholesalers, and customers to continue to push the message and the education around these products.”