US biosimilars watch: similar but not déjà vu

Our latest Special Report is a review of key factors impeding progress of US biosimilar adoption written by Helen Ji (pictured above, left), an associate at Schiff Hardin LLP, Rekha Hanu (center), executive director and chief IP counsel at Akorn Pharmaceuticals (Nasdaq: AKRX) and Christine Simmon, SVP for policy and strategic alliances at the Association for Accessible Medicines.

Biosimilars, or follow-on biologics, have the potential to offer safe and effective treatment at a lower cost than a reference biologic. But despite great anticipation, biosimilars have seen relatively slow growth in the USA.

Moving forward, we can apply many lessons learned from generic small molecule drugs, which similarly faced slow growth in the 1980s and yet currently account for nearly 90% of prescriptions in the USA. Nevertheless, the additional regulatory, legal, scientific, and public perception issues unique to biosimilars will create new challenges.