FDA Approves New Drug to Treat Crohn’s Disease

April 11, 2016 | By admin

A new drug that could cut down on deadly autoimmune diseases has been approved by the U.S. Food and Drug Administration (FDA). The drug, known as Inflectra, was developed by Celltrion and is expected to be co-marketed by both Celltrion and Pfizer.

Inflectra is a “biosimilar” version of Remicade, which is already used by doctors to treat Crohn’s disease and rheumatoid arthritis. The drug is known as a biosimilar because, while artificial, it is very similar to a biologic medication that can be produced by living cells.

The hope is that the biosimilar nature of the drug will help to lower the costs of medications that have existed for a long time but that remain extremely expensive. The IMS Institute for Healthcare Informatics found that biosimilars like Inflectra could have a substantial impact on the costs of pharmaceuticals, with one estimate suggesting that the United States could save more than $250 billion over the next decade because of the development of biosimilar drugs.

Celltrion and Pfizer sought, and ultimately received, approval from the FDA to use Inflectra to treat a number of diseases and medical conditions, including:

  • Crohn’s disease
  • Ulcerative colitis
  • Rheumatoid arthritis
  • Active psoriatic arthritis
  • Ankylosing spondylitis
  • Severe plaque psoriasis

One concern about Inflectra, and other biosimilar medications, is that they could potentially have a negative effect on health if not properly used. Although the FDA determined that there were no “meaningful differences” between Inflectra and its biologic counterpart, the drugs are not necessarily interchangeable. That means users of Inflectra, or some other biosimilar, could react differently to the different medication. Only time will tell if the use of biosimilars like Inflectra will lead to a rise in product liability or medical malpractice lawsuits.

To learn more, read the Yahoo.com article, “A New Drug That Could Save the US Billions of Dollars Just Got Approved.”


If you or a loved one has suffered an injury or illness due to a defective product, or due to the negligence of a doctor or physician, you should speak with a qualified product liability and medical malpractice lawyer. The experienced product liability attorneys at Lombardi & Lombardi can help you explore your legal options and secure the compensation you deserve. Contact us today to schedule a free consultation at one of our offices in Edison, Brick or Freehold, NJ.


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