The approval of Inflectra Tuesday is only the second time that the Food and Drug Administration has approved a quasi-generic biotech drug for the US market. The FDA said that Remsima – a biosimilar version of Johnson & Johnson’s Remicade (infliximab) – is effective for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, pediatric and adult Crohn’s disease, psoriasis, and psoriatic arthritis.
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Inflectra’s most common clinical side effects included respiratory infection, headache, cough, and stomach pain.
The FDA’s decision to approve Inflectra has come on the back of data from various sources, exhibiting structural and functional characterization as well as safety and effectiveness of the biosimilar.
Inflectra has a boxed warning to alert health care professionals and patients about an increased risk for serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis and invasive fungal infections (such as histoplasmosis). In fact, Remicade is Johnson & Johnson’s top-selling medicine with sales of $6.56 billion previous year. Founded in 2002, Celltrion focuses on promoting the health and welfare of patients in need of innovative biopharmaceutical products through world-class manufacturing and research facilities, developing state-of-the-art technologies, and establishing quality systems. In 2014, the latest year data is available, six of the 10 best-selling medicines globally were biologics, with about $49 billion in combined sales. Shares of the troubled Canadian drug company soared Tuesday morning.
That’s because the drug was just a 15% discount off Neupogen’s list price.
Remicade belongs to a very successful class of anti-inflammation drugs, known as TNF inhibitors, which work by blocking the function of a protein called Tumor Necrosis Factor. Merck & Co sells Remicade in Europe.
In a statement released by the American College of Rheumatology, Joan Von Feldt, MD, MSEd, the group’s president said, “The safe adoption of biosimilars into the [United States] U.S. marketplace remains a top priority for the American College of Rheumatology (ACR)”.
To obtain approval, a biosimilar must have the same mechanism of action, route of administration, dosage form and strength as the reference product, and only for the indications and conditions that have been approved for the reference product.
Other blockbuster biotech drugs expected to face US competition in coming years include AbbVie’s anti-inflammatory drug Humira, which is from the same family as Remicade.
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Humira, also one of the top-selling drugs in the world, dominates the current market of RA treatments. During a February 2016 Arthritis Advisory Committee hearing, the ACR provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the United States.
