The FDA has handed an approval to Teva for its biosimilar of the aging neutropenia drug Neupogen. But the significant barriers that lie between that treatment--tbo-filgrastim--and any kind of significant market share underscores just how slowly these new therapies will begin to reshape the U.S. drug market.
Like Neupogen, Teva's ($TEVA) treatment boosts white blood cells in patients undergoing chemotherapy. But under a patent resolution pact Teva inked with Amgen ($AMGN), it can't start marketing its versions of Neupogen or Neulasta until late next year. And with a clearly abbreviated regulatory pathway for biosimilars appearing only now, Teva had to go through the standard development process in order to gain FDA approval. Once it is on the market, Teva can't market the treatment as substitutable for Neupogen--a billion-dollar product. It will have to start from scratch to go after a market Amgen has dominated for years.
In Europe, where it is being marketed, the treatment has snagged 5% of the market.
"While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share," noted RBC Capital Markets analyst Michael Yee, Reuters reported.
To gain an approval Teva recruited 348 patients and demonstrated its efficacy over a placebo. The treatment was also subjected to three safety studies.
In the world of oral drugs, a well-established generic approval process has created a perfect storm for companies losing patent protection for their blockbusters. Almost instantly competitors spring up to grab market share, with payers driving the process with formulary policies that require the use of less-expensive knockoffs. That scenario won't apply to biologics as long as anyone developing a biosimilar has to put it through extensive testing and then market it as they would any other new chemical entity. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.
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