The report - "Biosimilars: Parsing the Industry's Pipelines" – says biosimilars 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," said Moody’s SVP 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."
The EU has already seen biosimilar approvals of a monocolonal antibody in July, though the delay in the US may be more political than science-related. At a recent FTC (Federal Trade Commission) hearing, scientists and lawyers argued over the naming of biosimilars, as well as how and when they’ll be approved. A recent report from Frost & Sullivan also described the situation as akin to a market ready to take off.
Many of the largest branded biotech products in the US market today are now in biosimilar development, Levesque added, and the pipeline is expanding. Blockbuster biologics facing biosimilar competition include AbbVie's Humira, a rheumatoid arthritis drug, Amgen's Neulasta, which is indicated for febrile neutropenia patients, and Roche's MabThera/Rituxan, which is another rheumatoid arthritis drug.
Although the erosion curve is steeper for traditional pharmaceutical products, AbbVie, Amgen and Roche will face sales declines, Moody’s said.
"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,” Levesque added.
The new report from Moody’s includes a table listing biosimilar products currently in late-stage development for the US market, including the developers and patent expiries.