Pfizer filed a Citizen Petition with the FDA requesting regulators issue guidance to “…ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars….” With lagging performance from its Remicade copy, Inflectra, as the backdrop, Pfizer is calling BS on innovators’ communications regarding biosimilars, which Pfizer believes intentionally confuse consumers and prescribers and erode confidence biosimilars. Specifically, Pfizer notes how J&J describes that biosimilars act in a “similar” way to Remicade when, in fact, they employ the same mechanism of action. Amgen claims that switching to a biosimilar “carries risk” if your current product is working. And Genentech states that biosimilars are “highly similar but not identical” to branded products. Pfizer claims that’s only half the story. While Pfizer’s motives are almost certainly not altruistic in nature, they probably have a point about intentional marketing half-truths.
Apparently, regulators in Britain don’t think the price of biosimilar products is low enough. According to a consultation, “the average price decline upon loss of exclusivity is significantly lower for biological medicines than for non-biological medicines, with a ~70% average drop in expenditure for non-biological medicines compared to a ~45% drop for biological medicines.” One of the issues here is using averages. According to Warwick Smith, of the British Biosimilars Association, “we have seen price reductions of more than 80% for some products” and “these proposed changes will significantly impact biosimilars and manufacturers may be unable to launch products as a consequence. This could also impact the potential patient benefits of these medicines and threaten Simon Stevens’ objective of £300 million of savings in the next three years.” Everyone, simmer down and remember no biosimilars, no cost savings – period.
How would you feel about taking a biosimilar drug?
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…
If you thought the FDA was going to make proving biosimilar interchangeability a piece of cake…think again. Shocking, we know. Much to the delight of those who manufacture originator biologics, the FDA released its fairly stringent biosimilar interchangeability guidance last week. Folks, it ain’t gonna be easy. In order for a branded prescription to be switched out for a biosimilar without a doctor’s thumbs up, interchangeability with the original product has to be proven with complex switching studies. Unfortunately for biosim makers, many studies currently underway do not meet these switching study requirements. Hooray for innovation! Bummer for affordability.
How often does the US Supreme Court hear a case involving the pharmaceutical industry? We don’t know, but it’s not every day, of that we are pretty sure. Just last week the US Solicitor General (sounds made up, right?) called on the Supreme Court to review the six-month delays to biosimilar launches. Believe it or not, after (yes, after) the FDA gives the okay for a company to start marketing a biosimilar, the originator company has six additional months to identify any potential patent claims. Translation: originator companies get at least six more months of patent exclusivity. Translation of the translation: mucho dinero. So, yes, this is a big deal for the entire healthcare system in the US.
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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