BIOSIMILARS: LITIGATION CHALLENGES
CD: Could you provide a brief overview of the issues presented by biosimilars in the wider pharmaceutical sector? What litigation challenges are likely to arise?
Tellekson: The pharmaceutical sector will see increasing focus on biosimilars in the coming years. Many of the leading biologics, with an estimated worth exceeding $80bn in global annual sales, are expected to have their patent rights expire by 2020. And, in contrast to developing a generic small molecule – at an estimated cost of $2m to $3m – Sandoz recently estimated development of biosimilars to cost about $75m to $250m to reach approval, due in large part to the extensive clinical and comparability studies required to establish ‘biosimilarity’. With investments of these magnitudes, cost savings for biosimilars are not expected to be as significant as they are for small molecules. Yet, the introduction of new biosimilars is still forecasted to greatly increase access to many much needed biologics at reduced costs. With this magnitude of potential markets for biosimilars emerging over the next few years, it is certain that litigation will be part of most market entries.
Sukduang: The enactment of the Biologics Price Competition and Innovation Act (BPCIA) in March 2010 provided the regulatory and legal framework for the introduction of biosimilars into the US market. The BPCIA, however, left many unresolved issues, including the criteria the FDA would employ to assess biosimilarity, the extent of human clinical trials the FDA would require, and whether biosimilar products would have a different name from their branded counterparts. The FDA has addressed some of the regulatory questions through issuance of Final Guidance documents to the industry. The FDA’s recent approval of Sandoz’s Zarxio product, a biosimilar to Amgen’s Neupogen, also provided additional insights, including the FDA’s willingness to extrapolate from one indication to several others, and the ability to reference clinical trials and prior commercialisation of the biosimilar product in foreign countries. Many unanswered questions, however, persist on the litigation front. The BPCIA introduced a patent exchange process requiring biosimilar applicants and biologic sponsors to confer on which patents might be asserted in litigation. If this process is completed, it could take up to eight months before a complaint is filed – a significant amount of time considering the FDA’s goal to approve biosimilar applications within 10 months.
Jul-Sep 2015 issue
Fenwick & West LLP
Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
Green, Griffith & Borg-Breen LLP