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.
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, 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.
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“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.
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“Oncology represents the highest number of pipeline biosimilars, followed by immunology and metabolic disorders; this reflects the patent expirations of key monoclonal antibodies (mAbs) in oncology, immunology, and diabetes. It is these categories of biosimilars that are expected to most strongly drive the market,” Trewartha said. Key patent expirations in these areas include drugs such as Avastin, Humira, Levemir, among others (See Table); the entry of biosimilars into these respective markets is expected to follow.
The high success rate and lower side effects of mAbs (when compared with traditional treatments) are driving the biosimilar market, said India-based Mordor Intelligence, in a written report supplied to Drug Topics. Although these drugs have been widely used in the treatment of cancer, autoimmune diseases, and inflammatory disorders, they are also being clinically tested for a wide range of diseases.
The market is further fueled by the growth of concurrent disease states, according to Mordor. Cancer is one of the leading causes of death in many places around the world. It is the second leading cause of death among both men and women in the United States, according to the CDC. The incidence of cancers are also increasing in low- and middle-income countries. Diabetes incidence has also escalated in recent years, according to Mordor. With the increasing disease incidences in low- and middle-income countries, the demand for biosimilar drugs is expected to increase, thereby driving the global market.
Generally, legislation on interchangeability of a biosimilar with its originator product dictates the extent to which prescribing pharmacists are able to switch to the lower-cost biosimilars without the intervention of the prescriber. “In Europe, the decision on the interchangeability of biosimilars is made by individual countries, while in the United States, the relevant legislation differs from state to state, meaning the rules and processes can differ considerably,” said Trewartha.
On the front line, Shank said the use of a biosimilar is generally driven by a patient’s insurance coverage. “In the case of filgrastim, for example, the insurance formulary dictates which type of product is dispensed. This can be quite complicated for procurement of the drug as the retail/specialty pharmacy may need to carry several types of filgrastim to meet the demands of the formularies.”
Health-care professionals may have some apprehension surrounding biosimilar drugs, asserted Shank. “Health-care professionals are unfamiliar with the approval process and amount of data available,” he said. “The standards for the studies are still being developed. Health-care professionals may not be comfortable with extrapolating the data over all indications for all patient populations. Additionally, immunogenicity in such small studies may not become evident until the product reaches the market,” he said.
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Patient education is also a challenge, he continued. “Biosimilars are so new it is difficult to educate patients on the exact process. Depending on their health literacy, I explain that a biosimilar is another available product. It is critical to not explain this as generic versus brand. Biosimilars are a completely different game,” he said.
Shank noted that it is currently unknown what the fate of biosimilars will be if or when the Affordable Care Act is repealed. “Most experts feel the abbreviated biosimilar approval process in the Biologics Price Competition and Innovation Act will remain.” But, he concluded, “time will tell what will happen to biosimilars.”
1. Huml R, Rulewski N, Biosimilars in the US: How to navigate this soon to be booming development plan. Available at: http://www.quintiles.com/blog/biosimilars-in-the-us. Accessed July 25, 2017.