The FDA decision on Mylan N.V.’s (MYL) biologics license application for MYL-1401O, a proposed biosimilar to Roche's breast cancer med Herceptin, is expected to be announced by December 3, 2017.MYL-1401O, which is co-developed by Mylan and Biocon, was unanimously recommended for approval by the FDA’s Oncologic Drugs Advisory Committee in July. In March of this year, Roche provided a global license for Mylan to commercialize biosimilar Herceptin in various markets around the world. In return, Mylan agreed to withdraw its pending Inter Partes Review (IPR) challenges against two U.S. Genentech patents. Roche’s Herceptin recorded sales of about $6.7 billion in 2016 and $3.6 billion in the first half of 2017. If approved, MYL-1401O will be the first Herceptin biosimilar to secure the FDA nod.Ontruzant, developed by Samsung Bioepis, a South Korea-based joint venture between Samsung and Biogen, which received approval from the European Medicines Agency on November 20th, is the first Herceptin biosimilar to be cleared in Europe.MYL closed Tuesday’s (Nov.28) trading at $36.88, up 1.15%.