2. No cakewalk for biosim interchangeability says FDA

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.

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1. A supreme (court) biosimilar battle brewing

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.

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A HealthyDose™ of Biosimilars

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.

Click the picture or click here to see it in high resolution.

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3. FDA amends citizen petition rules

The FDA announced an amendment regarding citizen petitions that will impact branded drug makers. A citizen petition is supposed to be submitted to the FDA if the safety or efficacy of a drug is in question. The drug is then delayed or blocked from going to market. Some companies have instead used this process as a tactic to protect sales of their drug against would-be competing biosimilars and generics. But effective January 9, 2017, a citizen petition will not be considered if the drug in question “[does] not raise valid scientific and/or legal issues.” Industry lobby group PhRMA has issued requests regarding the amendment, most of which the FDA has rejected. You can bet the battle is far from over with companies’ patents in play.

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1. South Korea… winning

Remember the supply-demand curves you learned about in economics class? No? Guess who does remember them. Spoiler alert… it’s South Korea. To better understand what we’re talking about, go ask your friends in the industry who are responsible for manufacturing biologics if they think there is enough industry capacity (supply) to handle future demand. For those of you who don’t have friends, the answer is definitely “Not even close.” A little secret, South Korea knows this and has been building plants to take advantage of the divergence in the supply-demand curves. It’s probably no coincidence that Samsung announced in late 2015 that it is building the world’s largest biomanufacturing plant.

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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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