In the wake of the landmark Supreme Court decision, Americans should consider the Affordable Care Act’s implications beyond the individual mandate and other politically divisive provisions. Specifically, the healthcare legislation contains language that will enable imitative versions of biotech drugs to be approved and sold in the United States. Now that the legislation has been upheld, the Food and Drug Administration (FDA) can continue its work to develop a pathway for the eventual approval and sale of biosimilars and bring more Americans greater access to cutting-edge biologic medicines.
Biotech drugs, otherwise known as biologics, are highly complex drug therapies for patients diagnosed with some of life’s most challenging diseases like cancer, rheumatoid arthritis, and Multiple Sclerosis. These medicines are extending lives and reducing suffering. What makes them so unique, as compared to traditional chemical pharmaceuticals, is that they are produced with organic materials like recombinant DNA sourced from bacteria, animals and humans.
Biologic products area a growing share of the U.S. drug market: they accounted for seven of the top 20 medicines sold in the United States in 2012. Despite their widespread use, there are no copycat or ‘biosimilar’ versions in the United States; unlike generic versions of traditional chemical drugs, which have been widely available for the past three decades.
There are no biosimilar versions of biologic products in the United States because this class of medicines was not included in the 1984 “Hatch-Waxman” legislation that regulates the generics pharmaceutical industry. At the time, these products were considered ‘too complex’ to regulate.
But in 2010, the Affordable Care Act included language to authorize the FDA to create a framework for the approval and introduction of biosimilars. The FDA is currently working on this.
A major challenge for scientists and regulators remains ensuring patient safety. Since biologics can never have identical copies, seemingly insignificant changes in the composition of these medicines can have unexpected or even harmful effects in patients.
As the FDA lays out an approval pathway for biosimilars, it must consider several factors to safeguard patient safety. First, clinical trials will be needed to ensure a biosimilar product is as safe and effective as the innovator product.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Second, because a biosimilar will never be the same product as the original biologic, a patient should be made aware if he or she is receiving the original biologic drug or its biosimilar. It is also important that the patient, working with his or her primary physician, fully understands the differences between the two products being offered.
And third, the FDA should give unique names to each biosimilar that comes on the market. This will help avoid any confusion between doctors, pharmacists, and patients over what medication the patient is taking. And it will help trace any biosimilar drug on the market that begins to cause unexpected side effects in patients. Knowing the specific name of the drug, patients can easily determine whether their drug is affected – and can learn what steps to take to prevent or mitigate the side effects.
The Supreme Court decision gives the FDA the opportunity to move forward in the development and approval of biosimilars. In the coming months and years there is tremendous hope for more patients to benefit from these novel medicines, as long as patients and doctors can be certain they are safe and effective.
