Biologics and Biosimilars

Biography

Biography: Stanton Mehr

Abstract

Nine years after the passage of the biologics and biosimilars price competition and innovation act, 14 biosimilar agents have been approved by the US Food and Drug Administration but only 4 biosimilars have reached the US market. None have been designated as being interchangeable with the reference biologic. Of these 4 available biosimilars, only one (filgrastim-sndz) has attained competitive market share in its drug category. Lingering patent litigation, aggressive rebating by reference manufacturers, and insufficiently aggressive pricing by biosimilar makers have contributed to the current situation. The federal government has taken recent action to alleviate specific challenges to biosimilar market entry. The biosimilar action plan announced in July by US FDA Commissioner Scott Gottlieb may be successful in clearing the path for biosimilar marketing, but the other action will need to be taken on a legislative level (e.g., drug rebates as a safe harbor). Biosimilars may also benefit from a move from Medicare part B to part D, where payers can employ more pharmacy benefit tools to restrict access to nonpreferred products. Payers can also employ preferred and nonpreferred specialty drug tiers to make biosimilars more attractive to patients. There are significant market opportunities in several drug classes, but biosimilar manufacturers will have to carefully balance the potential revenues with delayed launches, and the viability of their business model.