On July 1, 2019, Ha Kung Wong published "Will product drift cause a rift?" in Pharma Manufacturing. The following is an excerpt:
The U.S. is still in the nascent stages of biosimilars. In fact, the U.S. Food and Drug Administration (FDA) is so concerned about promoting biosimilars that they released a Biosimilars Action Plan (BAP) in July 2018 to better clarify how companies can obtain approval and to educate the public. With this, we've seen a significant increase of approvals, with half (10 of 20) of the total biosimilar approvals in the U.S. coming in 2018 or 2019.