The antibody knockoffs are coming--gradually. Today the European Commission made healthcare history with its first approval of a biosimilar antibody--Inflectra (infliximab)--which was developed by Korea's Celltrion and will be sold by generics powerhouse Hospira ($HSP). But the companies don't expect to file for U.S. approval until 2015 as they wait for the FDA to finalize its regulatory pathway.
The approval gives Hospira a clear shot at Remicade's $2 billion European market for rheumatoid arthritis, part of a $6 billion global franchise for J&J that has become one of the top targets in the biosimilars business. While Hospira has been winning approvals for other biosimilars in Europe, this is the first time one of the far more complex antibody blockbusters has been successfully copied and approved.
Now the market can begin to assess how much of a savings they'll represent for payers as most analysts zero in on likely discounts ranging from 15% to 30%. Celltrion execs are already on record asserting that they're planning 30% discounts for biosimilars, but there's no official word yet on the price.
"The rigorous scientific review and approval process by the EMA and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade. For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra, and for the future of biologic therapy," said Dr. Stan Bukofzer, Hospira's chief medical officer.
Over the past two years the biosimilars business has undergone some major changes. A number of early biosimilar efforts have foundered over the past year as development efforts ran into serious patent issues or faced higher-than-expected costs. Just a few weeks ago Teva Pharmaceutical Industries ($TEVA) and Lonza formally scrapped their struggling partnership aimed at developing a knockoff of Rituxan. But big partnerships involving players like Samsung and Biogen Idec ($BIIB) continue to forge ahead. And Novartis' ($NVS) Sandoz unit has 5 projects in late-stage development.
Celltrion's progress has also attracted a lot of attention. A few weeks ago news reports surfaced claiming that AstraZeneca ($AZN) was considering buying the company. But Celltrion, which has confirmed that it is exploring the sale of a stake in the company, said the AstraZeneca rumors were inacccurate and no deal had been confirmed yet.
- here's the press release