Compromise: Branded biologics, biosimilar firms reach hard-won agreement
- The FDA still has not formalized a definitive approval pathway for companies that are developing biosimilar versions of popular biologics, such as Novartis subsidiary Sandoz's copy of Amgen's Neupogen, which is named Zarzio (note: another version of this article may have inadvertently switched the company names; we apologize for the typo).
- Companies that manufacture branded biologics and companies that are developing biosimilars have now agreed to support state legislation to allow biosimilar substitution at the pharmacy level, but pharmacies must inform prescribers of such substitutions "within a reasonable time," according to FiercePharma.
- Experts do not think that biosimilars will become a competitive force in the market for at least another two or three years.
So far, two companies, Sandoz and Celltrion, have filed products for biosimilar approval in the U.S. The lack of a defined pathway has challenged developers as their efforts to stave off patent-infringement suits and expedite development have been stymied.
Full on competition between branded biologics manufacturers and companies developing biosimilars is not imminent, but in 2020, when many of the top-selling biologics start to lose patent protection, experts predict that biosimilars will become a go-to treatment option.