FDA Panel Recommends Approval for First 'Biosimilar' Drug

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee has recommended that a new drug be approved as the first “biosimilar” generic alternative to an existing biologic, which is a drug that has been produced by living cells.    

The Novartis cancer drug would be the first approved under the Biologics Price Competition and Innovation Act of 2009, which passed as part of the 2010 Patient Protection and Affordable Care Act. The law created a pathway to market for biological products that prove to be highly similar—biosimilar—to an already approved FDA biologic drug. 

While cheaper, generic versions of brand-name chemical drugs have long been available to patients, drug companies have been unable to develop exact copies of biologics. Introducing biosimilars, which are not identical to the original biological product but produce comparable results, has the potential to produce cost savings and help more patients afford necessary and often lifesaving treatments. Pew’s specialty drugs project is exploring policies that could reap such savings and help patients afford the care they need.  

The next few biosimilars [getting approved] will give us a much better sense for how this market is going to pan out and how much savings there could be for the health system,” Rand Corp. researcher Andrew Mulcahy told Modern Healthcare. In fact, Mulcahy estimated that biosimilars could save as much as $44 billion over the next 10 years.  

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