Big changes for your RA, maybe

And no, we are not talking about the person that let you drink in your college dorm room. Earlier this week Boehringer Ingelheim announced the FDA has approved Cyltezo, a biosimilar to AbbVie’s Humira. A year ago, the FDA approved Amgen’s Amjevita, another biosimilar to Humira. Cyzelto was noted to be “highly-similar” to the reference product. Good for BI. The FDA said that Amjevita is not an interchangeable product for Humira and placed a Black Box warning on the product. Bad for Amgen. But wait, there’re more. It really doesn’t matter. AbbVie has launched several lawsuits, so despite the FDA’s approval, neither Cyltezo nor Amjevita are commercially available in the US. Here is what Amgen and BI are thinking now. Oh, what a tangled web we weave…

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Not just for smokin’

Maybe tobacco can redeem itself for its bad reputation as being an addictive, cancer-causing vice. It turns out, a tobacco plant-based platform for biomanufacturing may be able to make monoclonal antibodies at just 10% of the cost it takes using mammalian cell line systems. PlantPraxis, a joint venture between the Brazilian company Axis Biotech Brasil and the Canadian biotech PlantForm Corporation, is breaking ground on a pilot production facility in Rio de Janeiro to aid in the development of a biosimilar for AbbVie’s Humira (adalimumab) in addition to other biologics in their pipeline. What is even better than saving tons of money? Saving time; and the plant-based platform can do that too, along with unlimited scale-up capabilities. Don’t sell the tobacco farm just yet…

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4. Good week for biosimilars

This week, United Health announced a proposal to drop Sanofi’s insulin Lantus and Amgen’s bone marrow stimulant Neupogen in favor of their biosimilars. AND THEN, the FDA approved Amgen’s biosimilar version of Humira. Good week for biosimilars, bad week for Lantus, and meh week for Amgen (especially since AbbVie is still suing for patent infringement). This is only the fourth biosimilar licensed by the FDA under the Biologics Price Competition and Innovation Act, but the true test will come if more payers, like United, drop the branded products completely. ICYMI: Biosimilar safety and interchangeability are still questioned by some.

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