In the January/February 2019 issue of The Patent Lawyer, Ha Kung Wong published "The Proposed Affordable Drug Manufacturing Act: Friend or Foe for Biosmilars." Here is an excerpt.
Biosimilars, biological products highly similar to and without clinically meaningful differences from an existing FDA-approved biologic, are finally on the rise. In fact, of the 16 approved U.S. biosimilars, 12 were approved in 2017 and 2018. Additionally, four biosimilars launched in the last six months, which is as many as were launched in 2015 through 2017 combined. The recent 2018 FDA Biosimilars Action Plan, laying out initiatives meant to increase research, development, and approval of biosimilars, demonstrates the government’s commitment to growing biosimilar development. However, at the same time, there is continued concern about rising drug prices, which the government is eager to address.