A biosimilar is a biologic therapeutic product highly similar to another approved biological medicine. Several factors contribute to the growth of the biosimilars market, including patent expirations, lower prices, chronic disease prevalence, and cost-saving initiatives. The market is expected to grow strongly during 2021-2026.
According to the market database, 2021 will likely be the year of the first interchangeable biosimilar. An interchangeable biosimilar meets additional requirements and should produce the same clinical result as the reference product for any given patient. Pharmacists could substitute for an originator brand without asking the prescribing physician for consent. Expectations are that the U.S. Food and Drug Administration (FDA) will approve at least one this year.
Biosimilar products aids in savings
As Americans recover from the pandemic-induced economic downturn, taxpayers and patients need savings. The availability of more affordable pharmaceutical products, like biosimilar, would alleviate high healthcare costs.
Biologics are complex injectable treatments that revolutionized the healthcare industry and changed the course of treatment for many diseases, including certain cancers, multiple sclerosis, and rheumatoid arthritis. The innovative and curative nature of these products, along with the rigorous research and development that went into creating them, has led to significant costs.
According to the market database, biologics can be expensive for many Americans, costing tens of thousands of dollars per year. Despite only accounting for 2% of prescriptions, they account for 40% of all prescription drug spending.
Fortunately, a ready-made solution is available: Biosimilar. A biosimilar is highly similar to and has no clinically meaningful differences from an FDA-approved innovator biologic. They provide lower-cost alternatives to health care providers who treat patients with a wide range of conditions.
These hold much promise in keeping prices steady for therapies across complex disease states. According to the market database, biosimilar not only cost less, but the competition they create in the market helps to drive down the cost of the biologics they reference.
Vital biosimilar products
Remicade (infliximab) is used in the treatment of arthritis, certain bowel diseases, and specific severe skin diseases. By decreasing symptoms and promoting or maintaining remission, the medicine improves the quality of life for those with these chronic diseases.
In oncology, Neulasta (pegfilgrastim) helps the body replenish white blood cells after chemotherapy. While chemotherapy works by killing cancer cells, it can also decrease the number of white blood cells in the body and lower the immune system, possibly causing Febrile Neutropenia (FN). More than 80% of U.S. patients with FN require hospitalization, according to a study of patient data from 2007 to 2010. Pegfilgrastim can boost white blood cells and, as a result, change the lives of many patients.
According to the market database, by 2025, biosimilar competition could help 1.2 million patients gain access to biosimilar and biologics. These innovative therapies have the potential to reduce overall medical spending.
United Kingdom’s Biosimilars market
New guidance on the licensing of biosimilar products that reduce unnecessary clinical trials is expected to put the U.K ahead of Europe and facilitate a boom in these essential life-saving medicines. This would be creating greater patient access and saving the National Health Service (NHS) hundreds of millions of pounds. A broader range of biosimilar could also be made available for less common conditions.
Regulation and innovation are not always natural partners, especially when it comes to medicines. It is appropriate in most cases that patients need to be offered treatments that have undergone rigorous regulatory processes, to assure everything is in the clear. People’s health cannot rely upon untested products or procedures, or those without extensive clinical experience.
Nevertheless, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has recently issued new guidance which can be undoubtedly deemed innovative. A bold approach based on the grounds of both science and real-world experience. Furthermore, it appears to have the potential to transform the U.K’s biosimilars market.
European Biosimilars market
According to the market database, no new biosimilar have been confirmed so far in 2021 in Europe. The number of approvals for biosimilars in 2020 was low compared to previous years. The biosimilars market of the U.S. is ahead of the European biosimilars market.
The first biosimilar, somatropin, was approved by the European Union in 2006. At present, the European market has just 11 biosimilars approved, significantly low compared to 29 approved for the United States.
Although 8 of the 29 approved biosimilar products will be launched in the marketplace only after 2023, the U.S Biosimilars market is propelling. The biosimilar launched in 2021 was Amgen’s rituximab agent, Riabni, approved by the FDA in December 2020. The biosimilars market and its 10-year business outlook can be understood using Global Market Database.