I have more than a few thoughts about biosimilars, but will provide a more extensive version of my views at a later date. For now, I would like to point to two significant new developments in the biosimilars field, both in the news this week. In the first, the FDA released a Draft Guidance that provides more details of the Agency’s approach to the nitty gritty of the clinical testing of investigational biosimilar products.1 In the second major biosimilar news of the week, Samsung (yes, Samsung the Korean electronics giant) announced that it is committing at least $2 billion dollars to developing biopharmaceuticals through two separate efforts. In one venture, “Samsung Bioepis” is partnering with Biogen Idec to develop biopharmaceuticals including biosimilar versions of Roche’s Herceptin anti-cancer antibody as well Sanofi’s Lantus diabetes drug.2 In Samsung’s other biologics effort, Samsung Biologics will work with Quintiles, the global contract research organization (CRO), to develop biologics for Roche and Bristol Meyers Squibb. Continue reading
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