Biosimilars have the potential to rake in $60 billion of revenue throughout the world by 2020, as many original drugs lose their patent protection by then, an industry expert said Wednesday.
“Many key biologics are losing protection by 2022, and eight out of 10 are losing patent protection in the EU,” said Per Troein, vice president of strategic partners at IMS Health, “This would be a crucial time for biosimilar companies to grab global market share.”
|IMS Health Vice President Per Troein talks about latest trends of biosimilar industry during the Bio Korea 2017 conference at Coex, southern Seoul, Wednesday.|
Troein made these and other points in the “future of biosimilar” session at Bio Korea 2017, which opened its three-day run at Coex, southern Seoul, earlier in the day.
Biosimilar drugs are copies of biologic drugs, which are made from living molecules to treat disease. Biologic drugs are much more complex than generic drugs, and therefore more costly and difficult to make than generics. Biosimilars copy the original and save development time and cost, serving as a relatively cheaper replacement in the pharmaceutical market.
“There is no longer any discussion on whether biosimilars are safe and equally effective as the original products,” says Troein. However, he cited the need for a “slightly different tracking system that traces production back to a particular manufacturer and a particular batch. Ultimately, improved regulation saves money down the road.”
Biosimilar drugs are gaining market share in the pharmaceutical market, especially in Europe where the regulatory environment encourage the prescription of biosimilar drugs. However, some issues, including low cost of generics, resistance to “switching” (doctors switching patient prescription), and patient reluctance, are some of the limiting factors to the biosimilar market worldwide, said the executive of the U.S. provider of information, services, and technology for the healthcare industry.
Troein commented on the importance of competition saying, “Competition drives down prices, not only for the price of the directly comparable product but also for the whole product class. Countries with the highest reduction show a decrease of 50 to 70 percent.”
However, competition remains a double-edged sword since it influences the originator’s behavior: originators are launching innovative, long-active or pegylated products without a price premium, in addition to effectively decreasing price levels due to its volume advantage, according to Troein.
Korea has a small biosimilar market, comparable to the size of Denmark. In this aspect, Troein finds Samsung Bioepis innovation in the market remarkable, citing that Samsung has taken a non-traditional angle.
Paul H. Song, vice-president at Samsung Bioepis, which jumped into the market in 2012, said, “When we first started, our presence was hardly recognized, but five years later, industry players know Samsung as the leader in the biosimilar industry.”
Samsung Bioepis built a robust pipeline consisting of six first wave and multiple second-wave drugs to flourish in the biosimilar market, Song said, adding that its core capabilities are product development, product pipeline, and global network.
“Our company differentiates itself from other companies by reducing development time through parallel development,” Song said. “Samsung is also looking at holistic solutions, such as inventing devices that patients can use easily at home, making it more accessible.”
Troein concluded his presentation on a hopeful note. “Although biosimilar companies must navigate FDA regulation and industry competition, I remain optimistic about the biosimilar market, and more patients will benefit in the long-run and cost savings will go toward balancing the overall healthcare budget.”
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