Omnitrope Clears FDA: Is the Next Hurdle Congress?
This article was originally published in RPM Report
The debate over an abbreviated biologics pathway took a big step forward with the Food & Drug Administration's approval of Sandoz' recombinant human growth hormone Omnitrope. The approval itself is precedent setting, but the bigger ramifications are political: the action steps up the pressure on Congress to address the issue head-on.
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It isn’t a 351K pathway drug, but it does set up an interesting comparison for sponsors using the formal biosimilar pathway compared to the 505(b)(2) NDA route.
A handful of follow-on biologics are already offered in European and American markets, but have yet to cause signifi cant brand erosion. Yet despite ongoing regulatory and commercial uncertainties, Big Pharma and small molecule generics companies have been making strategic moves to enter into the biosimilar arena. This article, written by experts from the Campbell Alliance, examines the current movement toward an abbreviated approval pathway for follow-on biologics in the US and assesses the potential impact on current biotechnology products. In addition, the article provides some insight into what commercial and reimbursement decision makers for biotechnology companies should be doing to prepare for the arrival of biosimilars.
An abbreviated pathway for follow-on biologics just missed getting tacked onto the FDA user fee/drug reform legislation. It will be years before proponents get another shot at creating an abbreviated approval pathway for the biotech copycats. So who won and who lost?