Welcome to the ninth edition of Biosimilars Newsletter, a quarterly publication dedicated to keeping you updated on current biosimilars news, including the global regulatory landscape, biosimilars articles and reports, and company news as reported by the company press releases. The “hot topic” for this edition focuses on Biosimilar Orphan Drugs and the Next Regulatory Challenge (including biosimilars to adalimumab, pegfilgrastim, and etanercept). It also contains an article on the European Commission Workshop and the latest company news in Biosimilars.