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Did you know that 46 new drugs and biological products were approved by the FDA in 2017 alone?1 This is more than double the number approved in 2016, and the market shows no signs of slowing, as we’ve already seen 31 approvals in 2018, with a whole quarter of a year remaining.

Evidence of this trend can be observed in the immunology market, which is experiencing rapid growth in both the biosimilar and biologic spaces. Gone are the days when we could count the number of immunology drugs on the market with our two hands. Today, the market is crowded with not only an abundance of originator biologics, but also an increasing supply of biosimilar products. Immunology drugs are one of the costliest treatment options for autoimmune diseases such as rheumatoid arthritis (RA), Crohn’s disease (CD), ankylosing spondylitis (AS), psoriasis (PsO), psoriatic arthritis (PsA), and ulcerative colitis (UC). However, they are also the only treatment available that targets the underlying disease itself, as opposed to only symptoms of the disease.

The high costs associated with biologics pose a significant barrier for many patients seeking treatment, and the emergence of biosimilars directly decreases the current cost burden on consumers. Furthermore, increased competition in the market will cause downward pricing pressures, compelling competitors to reduce prices of their originator biologics to avoid loss of market share.

Many biologics benefitted from a lack of competition for many years, as they were protected by favorable patent laws. However, patents covering a large number of market-leading biologics have expired or are on the verge of expiry in the coming years. An example of this would be AbbVie’s adalimumab product Humira, whose patent expired in 2016. This blockbuster drug accounted for over one-third of the total value of the immunology drug market in 2017. Although it won’t be an easy feat for Humira’s competitors to uproot the biologic’s market dominance, it is predicted that Humira’s shares will fall gradually after 2020 due to the entry of biosimilars and other new drugs.2 Similarly, Amgen, the developer of the top-performing biologic Enbrel, cites biosimilars growth as a cause for declines in sales in the company’s 2018 financial reports.

Following is a timeline of recent biosimilar developments:

  • Sept. 28, 2017 — Amgen and AbbVie agree to settlement allowing commercialization of Amgevita — Amgen to begin launching the adalimumab biosimilar in Europe in 2018
  • May 10, 2018 — YL Biologics Ltd., Yoshindo Inc. (Japan) Pharmaceuticals and Medical Devices Agency accepts the filing for YLB113, a biosimilar product of anti-rheumatoid arthritis biopharmaceutical Enbrel
  • June 15, 2018 — Sandoz presents new long-term and switching data for biosimilars Zessly (infliximab) and Erelzi (etanercept) for rheumatoid arthritis
  • June 28, 2018 — Lupin and Mylan Partner to commercialize Enbrel (Etanercept) biosimilar
  • July 27, 2018 — Sandoz receives European Commission approval for biosimilar Hyrimoz (adalimumab)
  • July 27, 2018 — Mylan and Fujifilm Kyowa Kirin Biologics announce positive CHMP opinion for Hulio, an adalimumab biosimilar
  • July 31, 2018 — Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar

In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share. Unmet needs in the immunology market, in terms of safer treatment and more convenient administration, will continue to drive the market and fuel development of new original therapies.

This article was originally published on Bioprocess Online, to continue reading please visit https://www.bioprocessonline.com/doc/will-biosimilars-trigger-the-next-wave-of-blockbuster-biologics-0001

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For over a decade, iData Research has been consulting and conducting market research for top industry players in the pharmaceutical, medical device, and dental industries. Contact iData to learn more about this immunology drugs market, which covers market forecasts, average selling prices and unit analysis for 5 diseases: Psoriasis, Ulcerative Colitis, Crohn’s Disease, Rheumatoid Arthritis and Ankylosing Spondylitis.