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    Biosimilars Market Taking Off in the United States

    After many years of speculation, a number of biosimilar drugs are hitting the U.S. market.

    The biosimilars market may finally be poised to take off in the United States. By 2020, the global biosimilars market will exceed $390 billion and account for up to 28% by value of the global market for pharmaceuticals, according to Stockholm-based QuintilesIMS.1 This growth of biosimilars could substantially cut health-care costs in the United States.

    “The loss of patent protection for commercially successful drugs is expected to be a key driver of growth in the biosimilars market,” said Dominic Trewartha, Managing Analyst for GBI Research, a London-based business intelligence provider. “Many biologics have recently lost or are set to lose patent protection over the next five years. Biosimilar drugs are expected to capture a significant share of the pharmaceutical market,” he said. By the year 2020, according to research from GBI, $100 billion of biologics will be exposed to competition due to patent expiration.

    Europe Is Ahead

    While Europe has had 27 biosimilars become available, the United States has been slower to embrace this trend. But now, the growth is accelerating. Following approval of the first biosimilar in 2015, three more have been approved in 2017, including Amjevita (adalimumab-atto, Amgen), a biosimilar to Humira. Five more approvals are pending this year.

    “Europe is over a decade ahead of the United States in the approval of biosimilars,” said Brandon Shank, PharmD, BCOP, Clinical Pharmacy Specialist at the University of Texas MD Anderson Cancer Center, Houston. “With the Brandon Shank, PharmDBrandon Shank, PharmDintroduction of the Affordable Care Act, biosimilars are gaining traction in the United States with the implementation of accelerated approval pathways.”   

    Biosimilar products are steadily gaining increasing regulatory approval,” agreed Trewartha. “It is expected that the growing acceptance of biosimilars by physicians and governments, and the accumulation of real-world evidence will continue to help build patient confidence with regards to the safety and efficacy of these products. This will further drive growth in the market,” he said.

    Interchangeability is more commonly allowed in the United States than in Europe, Trewartha added. The FDA published draft guidelines on interchangeability in January, which encourages sponsors to conduct studies that demonstrate that using a biosimilar drug will not affect efficacy.   

    “Biologics have managed to leverage higher prices, with the average annual price for biologics more than 20 times the cost of small molecule drugs, and particularly high in areas such as oncology,” Trewartha explained. Because the price of biosimilars is 30% to 50% lower than the original drugs, there are huge potential health-care cost savings, which in turn drives the market for biosimilars, he said.

    Related article: Supreme Court Ruling Raises Biosimilars’ Access

    “Biosimilars do offer a reduction to the health-care system,” said Shank. However, he cautioned that the initial cost might be higher, since manufacturers will need to scale up their manufacturing processes. “I would hope that over time, the efficiencies gained in these processes will pass on more cost savings.” Competition should further increase the rebates and contract pricing within insurance companies and group purchasing organizations, he added.  

    “In order to be successful in the biosimilars sector, companies must adopt the latest technology and quality initiatives, such as quality by design, design of experiments, and process analytical technology. They must also take a proactive approach in risk mitigation by compiling risk management plans and adopting production best practices outlined by industry associations and regulatory agencies,” said Rishikesh Mandiwar, Analyst at GBI.

    A robust biosimilars pipeline currently shows that there are more than 400 biosimilar drugs in the pipeline; one third are in the clinical development stage.

    Up next: Insurance issues

    Kathleen Gannon Longo
    Kathleen Gannon Longo is a Contributing Editor.


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