Lot’s of talk this week about biosimilar legislation as a means of reducing the cost of prescription drugs. It’s actually been an ongoing topic for many years in biotech circles and PBM consulting (www.wbcbaltimore.com). The current expense of biologic drug therapies and the expected growth into chronic disease states for conditions with much higher prevalence makes it major concern for those who are responsible for paying the tab.
The debate focuses on the need to provide patent protection for brand name biologics vs. the desire to offer patients and payors a lower-cost, ‘generic”-type alternative. Manufacturers cost of R&D must be adequately recaptured in order to insure a continued pipeline of innovative therapies. Payors complain about the huge expense. A single patient using a single biologic drug therapy may cost $400,000 annually. Fortunately, patients using biologics represent less than 1% of the population, yet it can eat up 20% of the drug spend. That number is projected to grow and to reach 45% of drug spending by 2030.
Of course, there are no real generic alternative available, due to the biologic nature of the drugs. 
Unlike chemical compounding that occurs in regular pharmacy (small-molecule drugs), biologics are created at the cellular level within proteins. Traditional pharmacy uses drugs that address symptoms of disease, and generics must be identical or bio equivalent to their brand name counterpart. Biologics try and fix the actual disease and cannot be replicated exactly.Biosimilars then, are drugs that are “sufficiently similar”to products already approved by the FDA. In fact, some have suggested that we not even call them biosimilar (the term used in Europe) as a descriptor, but prefer “follow-on protein.”
The FDA needs to define a pathway for biosimilars to be approved for use. Several issues that need to be addressed are:
1. Definition of what exactly will be considered a biosimilar;
2. Define what is a “reference product” and how many years of patent protection or exclusivity will be granted (proposed ranges have been 3-14 years. Senate proposal is 12 years);
3. Must include all biologics, current and those in development, including gene therapies and cancer vaccines;
4. Decide whether to use comparability clinical trials or rely on FDA discretion
5. Other issues include labeling, substitution and intellectual property rights.
Pharma has come out in support of biosimilar approval, as long as there remains an adequate period of exclusivity. 12 years appears to be the minimum they will accept. Lobbying efforts will continue to be extremely fierce!
