Did you know that 9 of the top 10 best-selling US biologics will have fallen out of patent protection by 2020? No?
Maybe you should talk to your doctor to see if a HealthyDose™ of biosimilars is right for you. Side effects include: euphoria caused by an acute awareness of feeling yourself getting smarter, accusations of being a know-it-all by your colleagues, and more euphoria due to objectively knowing you are in fact smarter than your colleagues.
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Janssen announced that an antidepressant medication, Esketamine, has been granted Breakthrough Therapy Designation by the FDA. If approved, Esketamine would be used to treat major depressive disorder with imminent risk for suicide, and would be the first new treatment of its kind in the last half-century. Not-so-depressed party-goers have known the drug for a while as “Special K” or something causing an out-of-body experience. Janssen’s Phase II data from May 2016 show that the drug could be on track to create a more positive (and legal) reputation, providing care for a condition that currently has no approved treatment.
J&J got a thumbs down from a US district court regarding a patent on its blockbuster drug, Remicade, opening the door for biosimilar entries to the US market. Celltrion and Pfizer’s Hospira have their infliximab biosimilar, Inflectra, ready and raring to go for a launch as early as October 3. The biosimilar is already available in Europe and has been stealing a significant chunk of Remicade sales. However, J&J is planning to appeal the court’s ruling and considers a biosimilar launch prior to the outcome of the appeal to be an “at-risk launch.” Whether Celltrion and Pfizer will take that risk remains to be seen. Also TBD is how formularies will treat the products post-biosimilar entry. Will Remicade be blacklisted in favor of its sure-to-be-cheaper twin?