A new generation of medicines, known as biologics, are becoming more widely used to treat rheumatoid arthritis, cancer, HIV, Alzheimer's, Parkinson's and many other debilitating diseases. Biologics are advanced prescription drugs that are engineered from living organisms.
Naturally, as they become more popular, manufacturers and patients are seeking ways to increase access to these life-saving and life-enhancing medicines. One way is to allow imitative versions of biologic medicines, known as biosimilars, on to the U.S. market.
Currently the FDA is considering the best way to allow biosimilars on to the market that will ensure patient safety and drug efficacy.
Last week, the FDA received dozens of comments to its draft guidance on the U.S. approval of biosimilars. As the name indicates, biosimilars are similar to but not the same as the brand-name biologic and they will not be available in the United States until the FDA finalizes the draft guidance.
Because biologics are medicines produced from living organisms, they are very different from traditional medication produced from chemicals. Due to that complexity, biologics are quite vulnerable to changes throughout the manufacturing process. Even minor changes could result in versions that are significantly different from the original product.
As such, there are many unanswered questions about biosimilars that remain including how much data are needed be able to declare them safe for use and how will patients react when a biosimilar is substituted for a biologic they have been taking?
Biological products offer incredible potential to improve treatment and patient care but regulatory policies concerning biosimilars must place a premium on patient safety. Biosimilars must be dispensed carefully because they are just that -- similar to a biological product but not an exact copy like a generic drug is to a branded one.
Doctors and patients alike must be aware that there is a difference and not mistakenly believe a biosimilar is equivalent to the original biologic product.
Under the law, after the FDA makes a determination of biosimilarity, manufacturers have the option of presenting additional evidence to the FDA to demonstrate that their biosimilar is so similar to the innovator product that the two are "interchangeable."
The FDA's recently released draft guidance is silent on "interchangeability" other than to say it will be determined sequentially after biosimilarity has been established. It also states that the FDA is continuing to consider the type of information required to establish interchangeability. I caution the FDA to proceed very carefully when making determinations of interchangeability.
States have automatic substitution laws that allow a pharmacist to substitute a generic drug for a brand name one without notifying the patient or prescribing physician. These laws are designed to save money. Since a biosimilar is not identical to its reference product, the FDA and state lawmakers need to tread carefully through this issue.
The FDA can look to other parts of the world where biosimilars are already available. The European Medicines Agency, which regulates biosimilars in Europe, advises that substitution decisions should be made in consultation with the prescribing physician. In addition, automatic substitution is against the law in several European nations; including France, Germany, Sweden and the United Kingdom, among others.
To deliver high-quality healthcare, transparency, facts and information are essential. The patient should have a clear understanding of the differences that exist between biologics and biosimilars and that this isn't your "typical" generic drug. And doctors, in consultation with their patients should determine the best course of treatment for their unique situation.
(Dr. Richard Dolinar is chairman of the Alliance for Safe Biologic Medicines and is a practicing endocrinologist.)
(United Press International's "Outside View" commentaries are written by outside contributors who specialize in a variety of important issues. The views expressed do not necessarily reflect those of United Press International. In the interests of creating an open forum, original submissions are invited.)
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