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FDA Advisory Panel Recommends Approval Of Remicade Knockoff

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A U.S. Food and Drug Administration (FDA) advisory panel has recommended the approval of Remicade knockoff Remsima for the treatment of arthritis.

Of the 24 panel members of the Arthritis Advisory Committee, 21 favored the approval of the so-called biosimilar drug.

No Difference

The panel says the test results of Remsima did not exhibit clinically significant differences between its effects and that of Remicade. Both drugs produced similar results against rheumatoid arthritis and another related disorder called ankylosing spondylitis.

The panel adds that Remicade and Remsima have similar levels of safety and effectiveness for other conditions that the former addresses. Such conditions include psoriasis and irritable bowel syndrome conditions like Crohn's disease and ulcerative colitis. The panel gave their positive feedback even though Remsima was not tested for such disorders.

Johnson & Johnson's Jay Siegel urged the committee to wait for the results of a Celltrion study that compared both drugs against irritable bowel syndrome.

"Only direct clinical comparisons of (Remsima) and Remicade in active irritable bowel disease can provide the requisite assurance," he said.

The FDA previously said that it may be appropriate to approve biosimilars for additional disorders for which a branded medicine has been licensed, even if the knockoff was not tested for it.

Dr. Steven Solga from St. Luke's University Hospital in Bethlehem, Pennsylvania agrees. He said the committee that it is not sensible to test biosimilars for each and every condition because such trials would be too insignificant to produce accurate results.

Pharmaceutical Wars

Although creator Celltrion Inc. and developer Pfizer Inc. received an initial positive response for Remsima, the road to success may be not easy to tread.

In 2015, Johnson & Johnson had an annual profit of $4.45 billion courtesy of Remicade. The company may not be keen to the idea of a knockoff decreasing its whopping sales.

Although Celltrion and Pfizer have not yet revealed the price of Remsima, it is expected to be far cheaper than Remicade.

However, it is not only a battle between Johnson & Johnson and Celltrion-Pfizer.

Amgen Inc. and AbbVie Inc. are looking at impeding the success of biosimilars by taking out new U.S. patents to ensure monopoly up until the 2020's and 2030's.

Such move may significantly hinder knockoffs from entering the scene beyond FDA clearance and beyond the expiration dates of the branded medications' original patents.

Looks like the pharmaceutical companies already had a preview of what might happen in the future if Remsima succeeds all the way. On Friday, the shares of Johnson and Johnson, Amgen and AbbVie took a sharp dip after FDA released a briefing paper in support of Remsima.

FDA's call

FDA typically goes with the recommendation of advisory panels, but that is not always the case.

If the FDA would approve Remsima, it would be the second biosimilar drug to be licensed by the agency. The first one is Novartis AG's Zarzio, which is a knockoff of Amgen's Neupogen. The drugs enhance white blood cells in post-chemotherapy patients. Novartis offers a 15 percent discount for Zarzio, with respect to Neupogen's price.

Photo: Sarah Reid | Flickr

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