If the biological developed by Novartis to imitate Amgen's Neupogen is approved by the FDA, it'd open floodgates as other biosimilars find their way to the FDA's doorsteps. The cheaper alternatives would prove a tremendous cost-saving to the healthcare industry.
The first attempt in the U.S. to bring to market cheaper imitations of expensive biologic drugs gained support from U.S. regulators.
Novartis AG (NOVN)’s imitation, or biosimilar, is “highly similar” to Amgen Inc. (AMGN)’s blockbuster cancer medicine Neupogen, FDA staff said today in a report. FDA advisers will consider the report when they meet Jan. 7 to make a recommendation on whether the biosimilar should be approved for all five conditions Neupogen is sold to treat, most which help increase the white cell blood count of cancer patients.
Neupogen, which generated an estimated $1.2 billion in sales for Amgen in 2014, is part of the growing class of biologic medicines, which are more complex than chemical drugs. They also are typically more expensive and, unlike chemical drugs, have never faced generic competition before. The U.S. may save at least $44 billion in drug spending in the next 10 years by introducing biosimilars, according to Rand Corp.
Read the complete report on Bloomberg: http://bloom.bg/1vUhn1z