A recent policy review identifies factors that prevent the effective launch of oncology biosimilars (Lancet Oncol. 2020;21[12]:e575-e588. doi:10.1016/S1470-2045[20]30485-X).
Biosimilar regulatory approval pathways have been authorized in the EU, Japan, and the USA to facilitate approval of biological drugs that are similar to the reference product. In some EU countries, pharmacists can substitute biosimilars for reference biologics. This is not allowed in Japan or the USA because of regulatory approval processes.
“It is apparent that the intersection of law and medicine is proving to be a bigger hurdle than anyone anticipated for oncology biosimilars. Rather than patients having ready access to less costly formulations of blockbuster cancer drugs, ‘Pay-for-Delay’ deals and a bevy of patent lawsuits by AMGEN and Genentech/Roche hold the oncology biosimilar market hostage. Under the Biden Administration, dramatic changes in these barriers must occur if the U.S. is going to catch-up to the success that is seen in the European Union and Japan,” stated Charles Bennett, MD, College of Pharmacy, University of South Carolina (Columbia, SC).
Authors suggest to address region-specific competition barriers and educational needs to improve the regulatory approval process and market launches for biologics and expand patient access to products.—Lisa Kuhns
