Biogenerics: A Quick Synopsis with a Final Rant
The litigation and regulatory approval process surrounding Sandoz Novartis Omnitrope is relevant in the long term for all protein-based medications such as Insmed. There are scientific, economic, and legal implications:
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Patent protection:
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The only fans of generic drugs are the consumer public. Researchers and financial backers hate to see somebody else piggy backing and earnng revenue off of their hard work. It cuts into profit and reduces the incentive and capital for further innovation.
But INSM is protected by intellectual property law in the US for the next seven years. So why should we care? Because iPlex will not leverage other indications with larger patient bases for several years. By the time that iPlex is able to fill its potential, generic marketers that never had to underwrite trials may be cutting into their market. I believe in the common good, but nevertheless...
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Safety and Efficacy Concerns
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Biogenerics based on simple proteins are not simple. But larger and more complex formulations are extremely difficult to manufacure on a large scale; and require even stricter quality control. Competitive manufacturers of generics may have less incentive and capitalization to fully investigate side effects and enforce rigid production quality standards, the lack of which has given us things like thalidomide...
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Regulatory Aspects
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The FDA is holding up Omnitrope because it is afraid of setting a precedent that will open the flood gates and allow large protein analogue products to slide through on the tails of the original patent holder. Most complex protein biologics are regulated under under Section 351 of the Public Health Service (PHS) Act which currently does not provide for generics. A small number are handled under the 505(b)(2) statute which does allow for generic drugs. FDA is deferring to Congress, which will have to legislate any changes to the PHS Act.
And thus I begin my rant:
Good for the FDA. The drug addicted public wants cheaper drugs -- I say keep them more expensive if that will help to maintain quality and safety. If it goes into your body, buy the best. We are not dealing with placebos or vitamin supplements here. While I am not a scientologist, I do believe that contemporary Western medicine places an undue and excessive emphasis upon medication in maintaining and recovering health. There seems to be a pill for everything. In those situtations where medication is absolutely required, we should be focused on prescribing fewer drugs with fewer side effects. Outside of oncology, less is more. Which is why I favor iPlex over Increlex.
