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.
Kuyler Doyle and Kevin Barnett
A drug manufacturer can currently seek market approval for a follow-on biologic through existing regulatory channels following patent expiration, although there is currently no abbreviated pathway established in the US...
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