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Biosimilars Ahead, Proceed with Caution

May 11, 2012
By Richard M. Dolinar, M.D., Chairman, Alliance for Safe Biologic Medicines

In today’s budget-constrained world, the goal for health care is not only to save lives but also to save money. On Friday, May 11, the Food and Drug Administration (FDA) will hold a one-day public hearing on important medicines, known as biosimilars, that are under FDA consideration to come to the United States (U.S.) and offer the opportunity to help achieve the second prong of the health care goal: to save money. However, similar to any new medicine approval, patient safety must be paramount.

Biosimilars are attempted copies of innovative biotech medicines that have been available in the U.S. for a number of years. As members of the biotech community know, biologics have revolutionized the treatment of many serious and life threatening diseases in the short history of this industry. Biosimilars offer the hope of bringing life saving biologic drugs from the bench to the bedside in a cost effective manner and serve as another tool in the toolbox of healthcare providers. Unlike traditional pharmaceutical drugs that are made from chemicals and have structures that are well characterized, most biologics are made from living cells, with highly complex structures that are not easily understood, characterized or replicated. As a result, biosimilar medicines differ from generic drugs in that they are "similar to" but not exact copies of the innovator drug they attempt to replicate.

In 2010, the Patient Protection and Affordable Care Act (PPACA) granted the FDA the authority to approve biosimilars. Later that year the agency began consulting with patient groups, physicians and industry to exchange information that would eventually lead to the approval of biosimilars in the U.S. A few months ago the FDA took the first concrete step to create a pathway and issued draft guidance. The public hearing on Friday will allow stakeholders to provide testimony in response to the draft guidance and I am honored to be able to speak on behalf of the Alliance for Safe Biologic Medicines (ASBM).

In addition to my day job seeing patients as a practicing endocrinologist, I serve as the Chairman of ASBM, an organization that is working to raise awareness of biologics and biosimilars, as well as the important steps that should be taken to ensure safe use of these important medicines.   Our organization is composed of diverse healthcare groups—from patients to physicians, medical innovators, and others who have come together to ensure that patient safety is at the forefront of the biosimilars policy discussion.  We were pleased but not surprised to see the FDA lay out a science-based approach in the draft guidance largely building on the foundation laid by the European Medicines Agency (EMA).

The EMA began to establish the first formal regulatory pathway for biosimilars in 2003 and has gathered much data over the past 8 years that can, at a minimum help inform the development of policy in the U.S.  Policy makers should take advantage of this opportunity to learn from their experiences, both positive and negative.

We must also acknowledge that are differences between the EMA and FDA approach most notably in the area of “interchangeability” where the FDA has the authority to designate a biosimilar as interchangeable with its reference product and the EMA does not. This difference is not insignificant for patients in the U.S. because in theory it could lead to biosimilars being automatically substituted for the originator product by the pharmacist without consulting the prescribing physician. In the draft guidance the FDA signaled that it is not ready to prescribe a path to interchangeability at this time, and instead indicated that additional guidance will be necessary to better understand the challenges involved.

Differences aside, there is much to learn from the EMA experience and we believe that it provides a solid blueprint for the FDA to follow. At a minimum, ASBM members believe that the FDA must require biosimilar manufacturers to conduct clinical studies and produce analytical data sufficient to reassure patients and doctors that their products are safe. We also believe that unique nonproprietary names must be assigned to all biologic therapies so that physicians and patients know what caused an adverse event if one occurs.  Finally, as a practicing physician it is imperative that doctors and patients should be able to carefully choose the best course of treatment rather than have legislators and regulators decide for them.

For nearly 18 months, ASBM has been working to educate the public and policymakers about the great promise that biosimilars offer to patients in the U.S. Our message has been relatively simple, making lower cost medicines available to patients should be a priority but their availability must come with the absolute assurance that they are first and foremost safe. Our organization and its members have written Op-Eds, conducted webinars and hosted policy forums to exchange information about the issues and challenges associated with biosimilars. I am proud of the work we have done but ultimately realize as the late great Karen Carpenter sang so many years ago “we’ve only just begun.”

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