US: Biotech drugs need only seven years protection

Biosimilars/News | Posted 04/09/2009 post-comment0 Post your comment

Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.

Mr Waxman, a California Democrat and Chairman of the US House Energy and Commerce Committee, sent a letter to President Obama earlier this month asking him to discuss the potential savings from generic biologicals and what can be done to prepare the US FDA to regulate this new category of products. The White House is conducting “a serious review of FDA’s existing authorities” to ensure that the agency can quickly take on the role of approving generic biologicals once legislation is passed. Generic biologicals may be included as part of the Senate health committee’s plan to overhaul the US$2.5 trillion (Euros 1.78 trillion) US healthcare system, but lawmakers have not agreed to specific details for their proposal. The panel passed a bipartisan bill in 2007 that called for 12 years of exclusivity. The US lags behind Europe, where Teva, Hospira and Sandoz have won approval for copies of three biological drugs.

Amgen and Roche’s Genentech are the largest US makers of biologicals. They say their medicines cannot be replicated like conventional pills produced through chemical synthesis because of complex manufacturing and finished products that have slight variances. “Without a fair and sustainable cycle of investment and returns in innovative R & D, biotech discovery will be stifled,” said Mr David Polk of Amgen. “We look forward to working with Congress on legislation that strikes a necessary balance.” The US Biotechnology Industry Organization (BIO) has backed a measure from US Representative Ms Anna Eshoo that would set a high bar for approving generics and only after a brand-name product was on the market for 12 to 14 years.

Generic biologicals may be sold at a 10-30% discount, allowing for ‘substantial consumer savings’ without eroding market share for brand-name drug companies, the US Federal Trade Commission said. Amgen’s Epogen for anaemia and Neupogen to boost white blood cells after chemotherapy will probably be among the first biologicals copied in the US, according to Sanford Bernstein analyst Mr Ronny Gal. Both drugs already have competition in Europe.

Source: Bloomberg

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