According to a report this morning from Seeking Alpha, FDA is expected to approve Amgen’s application for a biosimilar version of AbbVie’s Humira (adalimumab) today. If approved, it will be the first biosimilar adalimumab product approved by FDA, and the fourth product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars…
We recently posted that Merck had announced “promising” results from Phase III studies evaluating MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes. Late last week, Merck announced that the FDA had accepted for review its New Drug Application…
Yesterday, CVS announced that it would be dropping two brand-name biologic drugs from its standard formulary (list of medications CVS will cover): Amgen’s Neupogen® (filgrastim), and Sanofi’s Lantus® (insulin glargine). CVS will be replacing Neupogen® with Sandoz’s Zarxio® biosimilar product, and will replace Lantus® with Eli Lilly & Co.’s Basaglar® product,…
United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is currently approved: rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. Asia: On July…
Merck, known as MSD outside the United States and Canada, announced promising results from two Phase III studies evaluating MK-1293 – Merck’s biosimilar to Lantus (insulin glargine). Lantus is used for the treatment of people with type 1 and type 2 diabetes. In both Phase III studies, MK-1293 demonstrated statistical…