Legislation Spurs Biosimilars
Hashmi identified biosimilars as a “hot topic” and an important part of the equation when navigating the regulatory landscape in Asia. Similarly, in the U.S., biosimilars and their evolving regulatory status are of significance. Timothy Shea Jr., J.D., a director at Sterne, Kessler, Goldstein & Fox, led a session of the BIO Discovery Theatre with a talk entitled, “The New Biosimilars Act: Overview of the Legislation and IP Implications.”
On March 23, President Obama signed the Biologics Price Competition and Innovation Act into law, following pressure from governmental and consumer advocacy groups to establish a biosimilars pathway in the U.S.
Currently, the top five Medicare expenditures are for biologicals, with EPO (erythropoietin) alone accounting for $2 billion. And while a traditional small molecule drug will cost about $2/day, a typical biologic may cost $44/day. Biosimilars represent a key strategy for reducing those costs. Other drivers include the fact that more than 500 biologics are in clinical development, nearly one-third of all new drug approvals will be for biologics, and patents for first-generation biologics have either expired or are soon to expire, with sales of off-patent biologics climbing to more than $20 billion/year.
Passage of the recent initiative is a starting point, but Shea pointed out that there is currently “no formal regulatory framework for approval of biologics in the U.S.,” and it will likely take at least two years for the FDA to establish such a framework.
Shea walked attendees through some of the intricacies of the biosimilars legislation, explaining that it recognizes two classes of products: biologics that are either “biosimilar” or “interchangeable” with a reference biological product. “Only biosimilar products that meet the higher interchangeability standard are eligible for market exclusivity,” he noted. Market exclusivity will be granted only to the first interchangeable biological product and will prevent other interchangeable products from entering the market for a defined period of time. However, biosimilar products can gain approval during the period of market exclusivity.
The Biologics Price Competition and Innovation Act requires that the FDA approve an application for a biologic if the applicant demonstrates that the biological product is either biosimilar to or interchangeable with the reference product.
Other distinctions between biosimilar and interchangeable biologics include the following: only interchangeable products can be substituted for the reference product without the intervention of the healthcare provider that prescribed the reference product; and biosimilar products are deemed to contain a new active ingredient, whereas interchangeable products are not.