- Generics makers Mylan N.V. and Biocon Ltd. look set to become the first to market a copycat version of Roche AG's blockbuster breast cancer drug Herceptin in the U.S., announcing last week approval by the Food and Drug Administration of their biosimilar Ogivri.
- Earlier this year, the drugmakers reached a settlement deal with Roche, securing a license to market their then-unbranded biosimilar Herceptin in most countries. Timing of a future launch in the U.S. remains unclear, however, and Mylan made no mention of when the drug would be available.
- Such uncertainty is typical of the biosimilar market in the U.S., which remains hampered by legal hurdles and patent litigation. Still, Ogivri is the eighth biosimilar to win an OK from the FDA, and more approvals look likely under FDA Commissioner Scott Gottlieb.
Approval of Ogivri comes three months late, after the FDA extended its review time by three months back in September. Even so, the drug is the first biosimilar copy of Herceptin to be waved through by the regulator.
The FDA OK'd Ogivri for all indications currently included on Herceptin's label and will also require the knockoff biologic carry Herceptin's boxed warning for the increased risk of heart disease, lung damage and embryo-fetal toxicity.
Two other copies of the breast cancer drug — Amgen Inc. and Allergan plc's ABP 980 as well as Celltrion Inc.'s CT-P6 — currently await a decision from the FDA as well, highlighting the growing threat to Roche from biosimilar competition.
Herceptin, along with the monoclonal antibodies Rituxan (rituximab) and Avastin (bevacizumab), currently make up a sizable portion of Roche's pharmaceutical revenues. Biosimilars could cut into those lucrative markets, although the Swiss giant believes it can stave off the worst effects of competition.
Amgen Inc. has won approval for its biosimilar copy of Avastin in both the U.S. and Europe, while biosimilar versions of Rituxan have begun to bite in Europe.
Yet, the steady drumbeat of approvals masks the legal and commercial difficulties biosimilar makers still face in marketing the cheaper biologics in the U.S. Of the eight biosimilars approved domestically, only three have actually launched commercially. Even after a launch, contracting can still crimp biosimilar sales, as Pfizer Inc. has found to its displeasure in its efforts to sell Inflectra (infliximab-dyyb).
That said, the FDA under Gottlieb appears committed to approving more biosimilars in an effort to rein in drug costs.
"The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs," said Gottlieb in a Dec. 1 statement. "This is especially important when it comes to diseases like cancer, that have a high cost burden for patients."