There is at least one bright spot in the recently passed health care reform legislation. Well, sort of.
The Patient Protection and Affordable Care Act finally established a much-needed regulatory pathway for “biosimilars.” Those are the generic versions of “biologics,” complex drugs made from living (or products of living) organisms, such as vaccines, insulin, human growth hormones and many others.
Innovator companies will get:
- 12 years of data exclusivity for their products, providing reasonable intellectual property protection;
- An arbitration mechanism to settle patent disputes; and
- A transition pathway to approve biosimilars, which have been regulated like traditional drugs despite their greater complexity.
That’s all good as far as it goes, but the legislation doesn’t address a number of issues. For example, the legislation did very little to address safety concerns in the approval of the biosimilars, leaving much of that up to the discretion of the Food and Drug Administration.
And the question is, will the FDA require clinical trials for biosimilars?
For a traditional drug, generic versions have to demonstrate “bioequivalence” with the drug they are copying, meaning they will have a similar therapeutic effect. That’s a relatively easy process given the simple molecules used in traditional drugs.
Not so with biologics. Thus, in order to assure the safety of biosimilars, some level of clinical trials should be required. Those trials can be smaller than the original trials sponsored by the innovator company, and that means less time consuming and expensive -- an important factor since the whole point of allowing a generic version of a drug or a biologic is to provide patients with a much-less expensive alternative.
That’s what the European Medicines Agency does, and it’s what the U.S. should do.
Biologics are the next wave of medical miracles -- and they are at our doorstep. Ensuring innovator companies have the necessary intellectual property protection to encourage them to invest in new biologic products was a major step forward.
Now let’s hope the FDA takes the necessary steps to ensure that biosimilars will be as safe as the medical miracles they are copying.