OP-ED

Op-Ed: Pathway for FOBs Should Balance Need for Competition and Need for Innovation

President Obama's first budget calls for the creation of a regulatory pathway for the creation of follow-on, or biosmiliar, biologics. This is obviously now the most high-profile call yet to move forward with a system that will provide the benefit of biotech drugs to patients who need them the most.

The biotech industry has done an outstanding effort in the last 10 years producing some of the most high-tech but also the most expensive drugs on the market. Some biotech medicines cost hundreds of thousands of dollars each year. Many of these products face no competition, because there is no legal way for a generic version of the product to get on the market. Individual patients as well as the healthcare system generally simply cannot absorb these continually rising costs.

To date, the debate over follow-on biologics has been mostly political posturing between the trade groups that represent the generic drug industry and the pioneering companies. The generic industry wants biotech companies to have only three to five years of market protection after bringing a new drug to market. The industry counters it needs up to 14 years of exclusivity to recapture its investment costs, which can reach over $1 billion for a single product.

In biotech's early years, when there were no products on the market, the industry liked to call itself the "good guys with the white hats." Back then, the pioneering companies didn't act like the large pharmaceutical companies and concern themselves with protecting profits or defending high prices, and the industry avoided the public scorn that big pharma received.

Now, with its top-tier companies making large profits, the biotech industry is in danger of falling into the same trap. Its only response so far has been political obfuscation. While visiting one Congressional office last year, a staffer told me that some biotech companies claimed follow-on biologics "would kill people." This does a real disservice to the thousands of biotech researchers who work overtime to bring innovative drugs to patients.

With the President's announcement, the handwriting is on the wall—follow-on biologics will become a reality. This will be good for patients. But patients will benefit only if the law appropriately balances the need for competition with the need to protect innovation. While the innovator industry needs to be open to competition, the generic drug industry must recognize that the biotechnology industry is one of the few industries in the United States that continues to lead the world and must be given ample and reasonable opportunity to recoup research costs.

In addition, the generics must recognize that good patient care demands that manufacturers show that their products are safe and effective before they are allowed on the market. For biologics including follow-on types, the only way to demonstrate this is through clinical trials, though, follow-on biologics should be on an expedited track without the full Phase I, II, and III trials. This should be required by law. The details should be left to the scientific experts at the FDA.

Technological and scientific advances have shown that biological products can be brought to market more efficiently while maintaining the highest standards of safety and effectiveness. Congress should develop a follow-on pathway guided by science and patient care.

Patients need these drugs now. What they don’t need is more of the same politics. The biotech industry should, as it always has in the past, support scientific innovations including those inherent in developing follow-on biologics and assist Congress in making this a reality.

Dr. James Bianco is CEO at Seattle-based Cell Thereputics Inc. This piece first appeared in Genetic Engineering News.

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  1. “The generic industry wants biotech companies to have only three to five years of market protection after bringing a new drug to market. The industry counters it needs up to 14 years of exclusivity to recapture its investment costs, which can reach over $1 billion for a single product.”
    Just five years to bring a new drug on market. That seems to be too fast, don’t you think so? We have to many low quality drugs, and from my point of view it will just increase it’s number.

  2. Bianco is right about the party line from the biotechs, and seems to have bought their core argument. We’re “the good guys” and our drugs are so different (and risky) that generic manufacturers should spend years and tens of millions of dollars before they replace our branded drugs. In practice, this means that the patents that the biotech patents began expiring in 2004 won’t stop yielding their monopoly rents for many years, until generic manufacturers have been forced to jump through a bunch of hoops.
    This is the genteel and “scientific” face of protectionism, not a response to public needs. The manufacture of biologics is complex, but not infinitely so. Many biologics will make great and safe generic drugs. And the price of listening to this siren song is billions of dollars we could legitimately spend on something else.
    The best way to protect innovation is to streamline the initial approvals, so these companies don’t have to waste the majority of their patent protection obtaining approval to market their drugs in the first place.

  3. Carl Parisien Natick MA – no doubt about it, is this the best way to do things? I mean really

  4. I sincerely hope the creation of a system for the FDA to approve generic versions of biologic drugs is implemented soon. There are good sides and bad sides to all drugs. What needs to be learned, and obviously sometimes the hard way, is how do drugs work. This is particularly true when they are biologics. They can be working in ways and speed that physician/scientists are not used to. It is a learning process – and of course – it can be a painful one. Biologicals carry specific risks, like immunogenicity, which limited information on the nature and timing of safety problems with their use have been identified. They may have very substantial risks involved in their use and underscores the need for closer scrutiny of these drugs.

  5. “…the generics must recognize that good patient care demands that manufacturers show that their products are safe and effective before they are allowed on the market. For biologics including follow-on types, the only way to demonstrate this is through clinical trials, though, follow-on biologics should be on an expedited track without the full Phase I, II, and III trials. This should be required by law. The details should be left to the scientific experts at the FDA.”
    I read somewhere that these much-vaunted “trials” had no requirement that new products were demonstrable better than those already in use. The trial only involved the new product against a “control group” receiving a placebo rather than a trial group using a competitive product.
    Please tell me how wrong I am. It will make me feel better.
    ===========================
    On another matter, if you professionals don’t stop generating acronyms us lay people are gonna pull out our hair in frustration. Kids with texting are already taking a toll on the language without yet another layer of acronyms from health care. I started doing my homework a few weeks ago and had to make myself a crib sheet to keep up.
    http://hootsbuddy.blogspot.com/2009/03/health-care-acronyms-crib-sheet.html
    Then last week I came across a link with nearly four hundred acronyms that prints out to six and a half pages! And FOBs didn’t make the cut.
    http://www.ecgmc.com/insights_ideas/healthcare_acronyms.asp
    I swear, there has to be a better way to communicate. Pretend it’s just another way to have a good “bedside manner.” (Or should that be shrunk to BM?)

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