In a new report on the global biosimilar drugs market, Biosimilars: Parsing the Industry's Pipelines, Moody's Investors Service reports that while biosimilar products have been launched in Asia and Europe, they are at least three years away in the US, the world's largest pharmaceutical market.
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilars."
Many of the largest branded biotech products in the US market today are now in biosimilar development by at least one company, Levesque says, and the pipeline is expanding. Blockbuster biotechs facing biosimilar development include AbbVie's Humira, Amgen's Neulasta and Roche's MabThera/Rituxan.
The downside risk for biotech companies is long term, rather than immediate, but the most exposed will be AbbVie, Amgen and Roche. While the erosion curve will be much less steep than it is for traditional pharmaceutical products, those companies are among those that will face sales declines, Moody's reports.
But upside opportunities will be spread among many players, Levesque says. "While the biosimilar drugs market is still evolving, entrants include not only traditional generic players like Novartis and injectable pharmaceutical manufacturer Hospira, but a number of branded drug makers such as Amgen, through a partnership with Actavis, and Pfizer.
The new report includes a table listing biosimilar products currently in late-stage development for the US market, including the developers and patent expiries.