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Comment by s1artibartfast

2 days ago

Why isnt it rational?

You spend the 1 billion for a ticket to win 30 billion/yr for the next several years.

Is it rational to spend 1$ to make $100 10% of the time? A 99% failure rate would be break even.

> Why isnt it rational?

You can spend that $1B to win a new category or that same money to maybe be non-inferior to Keytruda, but maybe fail. I think copycat design does happen, but I mostly notice it when drugs are being developed simultaneously at different firms. Perhaps it happens more beyond this, I'm unsure.

Otherwise, it makes more sense to try to find an indication where you are approved and have no competition.

  • I don't think you are looking at this from the rational economic perspective.

    I'm not talking about biosimilars or strict copycats.

    Completely novel indications are a tiny portion of Pharma development.

    Lucrative and technologically viable untreated indications are few and far between.

    Meanwhile, you have huge proven markets for treatments that impact millions of people with corresponding Revenue.

    If you are skeptical, you can simply go look at the development Pipelines for the top 10 pharmaceutical Giants and see how many of their new programs are for indications with existing treatments versus orphan.

    In recent years, approximately one-third of all novel new drugs approved annually by the FDA have carried a Breakthrough Therapy Designation. This corresponds to drugs that claim a substantial improvement over the standard of care for their target disease.

    • Understood, I responded elsewhere that I read the Lowe article as talking about conceptual advances (ACE, HMG CoA), but I realize he's mixing both erstwhile untreated indications as well as biosimilars.