With the approval of Zarxio (filgrastim-sndz), copycat of Amgen’s Neupogen (filgrastim), there has been much speculation on the word interchangeable vs. just a biosimilar, which is Zarxio’s status. According to FDA, a product is interchangeable if it is intended to produce the same result as the original in any patient. Janet Woodcock, CDER director, spoke recently on behalf of the Senate Subcommittee about how the FDA must wait until the guidelines are bulletproof before releasing to the public. Industry is frustrated as they want to obtain the higher interchangeable status but how to prove that remains unknown until FDA publishes final guidance.
Francis Megerlin, the Berkeley Center for Health Technology, stated that the growing use of interchangeable products could cause “a long-lasting competition for chronic treatments,” while also lowering prices by insurers. It is hard to say how much prices will decrease in comparison with the original products and it will have a different effect around the world.
To read Gareth MacDonald’s recent article on BioPharma, click here. To view a past discussion about this debate on businessinsider.com, click here.