US "biogenerics" rules: political battleground

With an unusually long drawn-out presidential election battle this year, the issue of approving a regulatory pathway for follow-on biotechnology drugs, also known as "biogenerics," is becoming a key area for lobbying efforts and attempts to mark a position by candidates. The Biotechnology Industry Organization is pushing for legislation which is more restrictive than that preferred by supporters of greater generic competition, but the indications are that, whoever is elected President in the first week of November, progress on this issue will be made.

Previously, the absence of a pathway has suited research-based firms who have argued that the Food and Drug Administration lacks the expertise to approve generic versions over concerns about whether biosimilar products can be manufactured that are identical to the branded product. However, a combination of pressures, not least the existence of a biogenerics approval pathway in the European Union, appears to have prompted the BIO to press for a favorable deal which offers a compromize between the patent owners and would-be competitors.