11/06/2014 11:56 am ET Updated Jan 06, 2015

Biosimilars: Another Untold Story of the Affordable Care Act


As the 2014 mid-term election season nears its final days, the American public has been saturated by a flood of campaign advertisements and literature attacking and promoting the Affordable Care Act (ACA). Were it not the political lightning rod that it has become, many more Americans would have a much clearer understanding about the ACA's wide breadth and how some of the law's policy changes, which are not featured in those campaign ads, will benefit them and their loved ones. In addition, a good number of these changes will significantly advance healthcare quality and science in our country.

One sweeping policy and regulatory innovation under the ACA, of which most Americans are unaware, is the role that the Food and Drug Administration (FDA) now plays in the regulation and approval of biological medicines and their biosimilar counterparts. This past summer, the first biosimilar applications were submitted to FDA for approval. These pending applications mean that patients and prescribers will soon have access to even more treatment options, since biosimilars are not currently available in the U.S.

Over the last two decades, it has been astonishing to witness medical innovations made possible through the advancement of biologics, and soon biosimilars. These advances have exponentially expanded the therapies available to both patients and physicians. Biologics and biosimilars can serve as innovative treatments for life-altering and chronic diseases, such as cancer and AIDS. In addition, they can be used as preventive interventions for the onset of deadly and debilitating diseases such as Alzheimer's, heart disease, Parkinson's, multiple sclerosis and arthritis. Unlike their pharmaceutical counterparts, biologic drugs are made from living organisms, primarily administered by injection or infusion and derived from more complex manufacturing processes.

In the months ahead, state legislators and regulators across the country will have opportunities to create laws and rules relating to the dispensing of biologic and biosimilar drugs. This has led to an earnest debate, currently taking place both in Washington, DC and in state capitals across the country, about how laws governing pharmacy practices can be updated to expand access to these drugs. While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars.

Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient's medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.

Ensuring that patient safety and access to these medicines is my paramount concern, and that concern is also a top priority for many other federal and state legislators and regulators who are engaged on this issue. Fortunately, many major drug manufacturers, including manufacturers of both innovator and biosimilar drugs, understand the promise of biosimilars and the need to ensure patient safety as they come to market. In addition to investing in the development of new biologics and biosimilars a number of these manufacturers are partnering with patients and physician advocates across the country.

All Americans deserve to benefit from the hope and promise of biosimilars: whether or not they recognize that their ability to access these new drugs is a result of the Affordable Care Act. As biosimilars become available to patients throughout the nation, there is an exciting opportunity for patients to be at the forefront of both medical innovation and patient safety. Patients throughout the nation, along with their families and physicians, are counting on their legislators and regulators to put patient safety first, as they advance critical legislation and rules to expand access to biologics and biosimilars.