Gary H. Lyman, MD, MPH, FASCO, FRCP

The availability of biosimilar products may improve access to healthcare by increasing the number of therapeutic options available at potentially lower costs. As of April 2019, 18 such biological products had been approved by the FDA, including 4 biosimilars for trastuzumab, 3 each for infliximab and adalimumab, 2 each for pegfilgrastim and filgrastim, and 1 each for rituximab, epoetin alfa, bevacizumab, and etanercept. The pace of approvals has accelerated, from the first indication for a filgrastim biosimilar in 2015 to 3 approvals in 2016, 5 in 2017, and 9 through early 2019, 7 of which were announced in the 2018 calendar year.