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.

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1. Better the devil you know than MRSA

Finally, some good news in the fight against antibiotic resistance… even if it’s a bit gross. A study published in Nature’s Scientific Reports found that the milk of the Tasmanian devil is effective in killing antibiotic-resistant MRSA and VRE bacteria. Young devils spend their first few months with incomplete immune systems hanging out in mama’s pouch. You may recognize an animal’s pouch as being slightly more pathogen-infested than your typical cleanroom environment. But it seems that peptides responsible for killing those bacteria are expressed in both the mother’s milk and pouch lining, protecting the joey. So yeah, new biologic sources are great and all, but we’re still a bit off-put by this. Maybe Taz can illustrate our feelings about it best.

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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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3. Move over mAbs, stem cell therapies are (almost) here

Great news for individuals suffering from rheumatoid arthritis and not so great news for pharma companies holding patents on the monoclonal antibody-based biologics currently used to treat RA. An Australian biotech, Mesoblast, completed Phase II clinical trials on its stem cell treatment for rheumatoid arthritis to astounding results (some have inserted the word “cure” here). In a test designed to identify whether the stem cell treatment is efficient—by achieving 20% relief of signs and symptoms—researchers instead saw a 70% improvement among more than one-third of the patients who received MPC-300-IV. Since some RA patients are unable to take biologics, a stem cell therapy could benefit wider audiences.

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4. If Johns Hopkins says so…

Researchers at Johns Hopkins Bloomberg School of Public Health found that biosimilar drugs perform as well as the brand-name biologics. They analyzed data from 19 studies of biosimilars that treat rheumatoid arthritis, inflammatory bowel disease and psoriasis to reach their conclusion. Many drug innovators, on the other hand, argue that biosimilars are not equivalent to their reference products and shouldn’t be used willy-nilly as a substitute. It’s complicated so don’t expect this argument to be solved definitively any time soon (or ever?). There are currently more than 50 biosimilars in development and the Johns Hopkins study could be weighty in terms of future product adoption.

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1. Pfizer spending a pot ‘o gold in Dublin

Ahhhhh, the lure of low corporate taxes. According to The Irish Times, Pfizer will be spending €300-400 million to expand manufacturing capabilities in its legacy Wyeth plant located in Ireland’s capital city. In spite of almost certain future competition from biosimilars, it seems Pfizer expects demand for its biologics to increase, including Enbrel—the Rheumatoid Arthritis blockbuster—and Prevnar—the vaccine for things we can pronounce but not spell. Increasing capacity to manufacture biologics is not quick. Pfizer expects to have the facility operational by 2020.

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