Musculoskeletal Network Launches Special Coverage of FDA Biosimilars Policy
NORWALK, Conn., Nov. 16, 2012 /PRNewswire/ — UBM Medica US announces that MusculoskeletalNetwork features special coverage of sessions from the annual meeting of the American College of Rheumatology (ACR), including the latest information about new FDA processes for approval of biosimilars that are like generic versions of expensive medications now used to treat painful rheumatologic conditions such as rheumatoid arthritis (RA).
Many newer “biological” drugs currently approved for these disorders, such as adalimumab (Humira) and rituximab (Rituxan), are identical to molecules created by the human immune system, except that these drugs are manufactured in cell cultures by bioengineering processes. Their high cost, which can run into the tens of thousands of dollars per month, should drop if manufacturers are allowed to sell identical “follow-on” products once the patent on the original drugs expires, just as less-expensive generic versions of other drugs are now on the market. Since the biosimilars would not be produced in exactly the same kinds of cells, there are concerns that they might not be as safe or effective as the original biological.
As part of the Affordable Care Act, the US Congress passed legislation in 2010 authorizing the FDA to establish policies to regulate biosimilars. In the article “FDA Panel on Biosimilars: Analytics Should Trump Clinical Trials” Musculoskeletal Network cites FDA officials at the ACR conference speaking to the specific concerns of rheumatologists attending the conference. These specialists are particularly interested in the issue as these drugs, used at first primarily to treat cancer, are now proving effective for many rheumatologic disorders such as lupus and forms of arthritis.
Also reporting from the conference, Musculoskeletal Network reveals promising results of pre-approval studies on prospective drugs for RA, which may be safer and more effective than the first oral medication for this condition, tofacitinib (Xeljanz). Tofacitinib was approved by the FDA only last week.
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Jason J. Golden
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SOURCE UBM Medica US