Biosimilars pose significant dollar threat to biotech cos.

WALTHAM, Mass. —The healthcare-reform bill that passed in the House in November has generated controversy throughout the country, but biotechnology companies may have reason to feel nervous.

According to a report from healthcare market research firm Decision Resources released early in November and titled “Biosimilars: TNF-Alpha Inhibitors and Interferon-Alphas in Immune and Infectious Diseases,” makers of tumor necrosis factor-alpha inhibitors for treating autoimmune disorders stand to lose $9.6 billion in sales in the United States, France, Germany, Italy, Spain and the United Kingdom by 2018 to biosimilar competitors, with increasing pressure on physicians from payers looking to save money. The report specifically named Amgen’s Enbrel (etanercept), Abbott’s Humira (adalimumab) and Remicade (infliximab) by Johnson & Johnson and Schering-Plough Corp., now part of Merck & Co.

The catch, of course, is that the United States currently has no regulatory approval pathway for biosimilars, and the Senate had yet to vote on its version of the healthcarereform bill at press time. Even if it had, several years most likely will pass before the first biosimilars appear on the U.S. market, as both the House and Senate bills provide for 12 years of data exclusivity. The Senate version would require an additional six months before the Food and Drug Administration could approve a biosimilar for children.

Meanwhile, in Europe, the only biosimilars on the market are follow-ons of Amgen’s anemia treatment Epogen (epoetin alfa) and chemotherapy side effect treatment Neupogen (filgrastim), and Pfizer’s growth hormone deficiency treatment Genotropin (somatropin [rDNA origin]).

“I think that you’re going to see virtually no biosimilar activity in the United States, with the exception to the human growth hormones that we have, until the beginning of the next decade,” IMS Health VP industry relations Doug Long told Drug Store News, referring to Omnitrope, a biosimilar version of Genotropin made by Sandoz, for which the FDA granted special approval in 2006. Long said biosimilar TNF-alpha inhibitors probably would begin appearing in Europe between 2011 and 2013. Monoclonal antibodies for treating cancer, and interferons for treating infectious diseases and certain cancers could appear down the line as well.

Whatever the time frame, the Decision Resources report illustrated the environment in which biotech companies could find themselves in the event of robust competition from biosimilars. Of the three TNF-alpha inhibitors specifically mentioned, Enbrel is one of the top-selling drugs in the world, with $5.7 billion in global sales, according to IMS data. On the whole, autoimmune drugs had global sales of $15.9 billion.

Physicians’ feelings about biosimilars also could influence the market. The Decision Resources report showed that gastroenterologists and rheumatologists had a “conservative” attitude toward biosimilar use relative to other specialists, but that discomfort with biosimilar TNF-alphas inhibitors would not prevent them from prescribing the drugs. They also would consider pressure from cost-conscious payers a motivating factor. “For the second year in a row, surveyed U.S. payers rank TNF-alpha inhibitors as their top priority for reducing biologics spend,” Decision Resources analyst MaryEllen Klusacek stated. “We anticipate that payer pressure on physicians to prescribe biosimilar TNF-alpha inhibitors will be high.”