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Biosimilars: Not So Dang Easy

This post drew a lot of comments here about how the big companies are going after follow-on biologic drugs. As a late-2008 article put it:

Merck already has one FOB in clinical development: a pegylated erythropoietin for anemia similar to Amgen’s Aranesp (darbapoetin alfa) called MK-2578, which is being developed using a sugar-modification technology the pharma obtained via its 2006 purchase of GlycoFi. The company hopes to launch its EPO product in dialysis and pre-dialysis patients with chronic kidney disease in 2012.
Clyburn declined to offer any sales projections for that product or the MBV unit in general, nor would he identify any of the other products or therapeutic areas Merck will attempt to develop. He said MBV will identify product candidates by looking at their value in the marketplace.

Good move to decline those speculations, because Merck just announced recently that they’re discontinuing that whole Aranesp-oid project. The FDA made it clear that they’d expect a full human cardiovascular safety workup before approval, which appears to have thrown Merck’s numbers off severely, as you might imagine.
There is, and continues to be, no easy way.

7 comments on “Biosimilars: Not So Dang Easy”

  1. processchemist says:

    Having worked on the scale up of some glycosidated small peptides I often wondered about all the whole protein glycosidation technologies thing. For sure the development of biologics (I have zero familiarity with this matter) must differ from the one of small molecules. But I don’t understand: fraction of similar MW can have a similar degree of glycosidation, but it’s enough to say that we’re talking about a material with an high grade of chemical omogeneity?
    A friend of mine works in the regulatory affairs office of a small company producing eparines, and he depicted the bioequivalence papers like a sort of nightmare (and we’re talking about a well known family of products).

  2. Hap says:

    I don’t know if I’m invoking the correct definition, but I figured biosimilars for biologic drugs nominally similar to current biologics but manufactured by different companies and potentially by different processes. (Theoretically, this would mean they may not be exactly the same, and hence require various levels of validation by FDA and a process from Congress to determine when and if they can be sold – in practice, there may be no possible generic for a biologic drug – FDA may never consider something as bioequivalent if it isn’t exactly the same, and, if simply scaling up means it isn’t the same, as Genzyme found out, then no one else can make a biologic without retrying it, with the attendant expense and cost to buyers).
    Merck’s (ex-)drug is more like a me-too/me-better drug – it was intended to be different from the biologic it was modeled after (and more effective), and probably couldn’t be considered the same by the FDA. It would have been more like Nexium than generic penicillin, with the consequent risks and potential profits. If me-toos always worked, we ought to have a whole lot more statins than we have now.

  3. Jerck says:

    Dr. Peter Kim’s head should roll and it is perplexing to many Merck watchers as to why he is still there. This guy scientifically ruined this great company that had a strong credentials in science over the years. He did so with wrong priorities at wrong time and with wrong people around him. MK-2578 was one among many started at his behest, starting with the purchase of Glycofi (a company used to be based in NH that uses yeast to express proteins). He also had notched several failures in late stage clinical trials. Given his track record, I foresee that he will oversee Merck’s failings in SIRNA (again, his initiative) and others. He has accumulated breathtaking record of disaster in a decade, while there.

  4. Anonymous says:

    Re #3 comments.
    The purchase of Rosetta for an incredibly inflated price should also be added to that list: ~$600 million as I recall, and then it disappeared with nary a whimper. Plus it brought along Stephen Friend. His partner in crime, Tony Ford-Hutchinson, should also be fired. He is the only legacy employee left in MRL from the productive days, during a time when MRL’s productivity has plummeted. I believe that Tony was the strongest advocate for GlycoFi, because biosimilars would have minimized risk. If I am not mistaken, Tony was also front and center for Vioxx – until the problems arose.

  5. Cellbio says:

    Hap, I think you have it mostly right, just add the freedom to operate issue driving development of novel molecules, and the game for Merck was supposed to be about grabbing a piece of the $8 billion dollar market for ESAs without much risk. They were aiming directly at Aranesp without, as much as I can tell, any real advantage in terms of efficacy or convenience, not taking aim at EPO.
    That was the plan, now add the risks revealed in recent years by clinical trials sponsored by Amgen, fueled by boneheaded marketing strategies that pushed dosage and hemoglobin target levels as a means to expand sales in a mature market, and the prospects for an Aranesp competitor look bleak.
    I wonder if the EPO biosimiliar people have any hesitations. I doubt it.
    I also wonder if there are data out there that track biosimiliar activity, like number of biosimiliars for a particular marketed product. I’ll bet there is a near perfect correlation with total sales. With the costs associated with biologics development, this means significant money going into developing products for already well served markets. It would be one thing of the offering would greatly lower healthcare costs, or offer a true improvement, but that is not the motivation of the companies I know of; hope I’m wrong.

  6. Thumper says:

    Check this link out for a take on the impact of the healthcare reform legislation on the development of generic and follow-on biologics. This is from a company that is actually developing generic biologics.
    http://seekingalpha.com/article/203466-momenta-pharmaceuticals-inc-q1-2010-earnings-call-transcript?source=yahoo&page=3

  7. Ashritha says:

    My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
    Various issues have been dealt with, such as:
    – Patent expirations
    – Regulatory frameworks
    – Infrastructure Requirements
    – Etc.
    If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

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