Jefferies analyst Michael Yee believes the 2018-2020 consensus estimates for Amgen (AMGN) may be too low if Mylan's (MYL) biosimilar of Neulasta doesn't get approved next month. The Biosimilar User Fee Act date is October 9. Investors may become more confident in the durability of Amgen's franchise given that AbbVie (ABBV) defended Humira and re-rated to a higher valuation, Yee tells investors in a research note. The key issue keeping Amgen's price-to-earnings multiple below peers at 12 to 13 times over the past couple of years is investor fear of biosimilars primarily against Neulasta and Enbrel, Yee argues. He sees a failed approval for Mylan as setting the tone for a higher multiple like AbbVie. The analyst has a Buy rating on Amgen shares with a $200 price target.

AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis. In this study, 46% of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen. A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group. The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.