By: Dina Khairo, B.Sc., MBA, Director, PAREXEL Consulting
Surprised?? It was bound to happen. October 10th saw President Trump endorsing and putting into action a Bill that has been tabled at the senate earlier this year to allow FTC review of settlements between biologic and biosimilar developers. In a multibillion dollar market of biologics, developers are keen to retain their market share under the looming threat of emerging biosimilars. Unlike their generic counterparts, biosimilars have been slower to enter the game – 1: complexity in regulatory review (clinical parameters for a biosimilar are product dependent); 2 – vagaries of US law for biosimilars and 3 – investment in manufacturing infrastructure for developers.
As FDA’s level of familiarity with biosimilar review evolves, and developers see the financial benefit of investing in the development of biosimilars, this law is an entry point for the Federal Trade Commission to ensure that the competitive environment is preserved, without having to go through the customary legal hurdles. What impact, if any, will this have on the biologics/biosimilar market is yet to unfold, however, one thing is for certain, it is yet one more ding in the biologic developers’ arsenal to stave off competition.
Navigating the commercial viability of the biologics market, in the context of a robust regulatory strategy to ensure a successful approval process for your biosimilar should not be tackled without the expertise of established entities like PAREXEL. With a proven track record in facilitating the approval of several critical biosimilars, worldwide, PAREXEL will be able to partner with you to unravel the evolving biosimilar landscape to help deliver faster, cost-effective therapy to patients.