Focus on Biosimilars: 2013 Policy Leadership Breakfast Recap

February 19, 2013

The introduction of biosimilars into clinical practice has become an increasingly hot topic, presenting new challenges that have not historically been present with small molecule generic medicines. In a lively panel discussion at MassBio’s 2013 Policy Leadership Breakfast, industry experts examined the role of biosimilars and the necessity for implementing sound public policies to ensure their safe and effective use.

Panelists included Dr. David Charles, Chairman of the Alliance for Patient Access and Chief Medical Officer at Vanderbilt University Clinical Neurosciences Institute; Professor William S. Hancock, Bradstreet Chair in Bioanalytical Chemistry, Barnett Institute of Chemical and Biological Analysis at Northeastern University; Fritz Bittenbender, BIO Vice President of Alliance Development/State Government Affairs; and Susan Nesci, Patient Advocate and Vice President of Public Policy & Advocacy of the Arthritis Foundation.

“It’s one of the hardest conversations as a health educator,” said Nesci. “Right now there’s no one-size-fitsall model. It’s trial-and-error with each patient. In a study last year, most patients stay on biologics for two years. We don’t want cheaper products that carry health risks. We want to see clear differences in the names of the products and patient providers should be notified if there is any change.”

Under the Biologics Price Competition and Innovation Act, a biological product may be demonstrated to be biosimilar if data show that, among other things, the product is highly similar to an already-approved biological product.

“As a dad, the idea of taking a generic drug – a pill – is one thing, but to inject a biologic is another,” said MassBio President & CEO Robert K. Coughlin, who moderated the panel. “Is it safe? And if there is a switch, it should be guaranteed that the physician is involved and the patient is involved, and that there’s some oversight and accountability.”

Bittenbender expounded on the fact that for biologics, the product is the process. Manufactured using living organisms, biologics are different and far more complex than most small molecule chemical drugs. Because the finished product cannot be fully characterized in the laboratory, manufacturers must ensure product consistency, quality and purity by making certain that the manufacturing process remains substantially the same over time. By contrast, a drug manufacturer can change the manufacturing process extensively and analyze the finished product to establish that it is the same as before the manufacturing change.

“The products are safe, but you want to know exactly what is being administered because a biosimilar may react differently in a person’s body,” said Bittenbender.

Because it is up to individual states to craft public policy around the approval of biosimilars, BIO has taken an active role in communicating with state lawmakers, making sure they are responsibly informed about the need to protect patient safety and preserve incentives to innovate.

“We’ve worked hard to develop principals for state policy discussions, focusing on access in the marketplace and patient safety,” said Bittenbender. “Patients need to be notified when they’re receiving a different product, and physicians need to be notified if a patient is receiving something other than what they prescribed. There also needs to be an increased standard for record-keeping at pharmacies.”

His fellow panelists agreed, and some called for even more accountability.

“Just receiving a notification is not acceptable” said Charles. “It should be a request – one that still engages the provider and patient in the decision process.”

While the debate regarding biosimilars will certainly carry on, one thing is certain – the availability of the products will continue to grow, affecting the treatment path of those with serious and life-threatening illnesses, such as cancer, multiple sclerosis, diabetes and HIV/AIDS, as well as many rare diseases.

“Thirty years ago, the first biologic came on the market, and today, they’re here to stay,” said Bittenbender. “Companies are absolutely going to make biosimilars, so this conversation is only going to take on more importance.”

The Policy Leadership Breakfast has become a must-attend annual event for policy makers, biotechnology, life sciences, healthcare and business leaders, and other key stakeholders. This year’s event was held on Jan. 23 at the Langham Hotel and attracted 220 attendees.

“As we enter a new legislative session, we are in the midst of some very, very significant changes,” said MassBio Board Chairman Geoff MacKay, who is President and CEO of Organogenesis Inc. “We are working with a federal government facing tremendous budget restraints, but committed to making healthcare accessible to all. This industry needs to have a voice among the new councils and committees forming and I implore you to join the conversation.”

To kick off the breakfast, MacKay was joined by Coughlin, who highlighted strengths of the Massachusetts biopharma industry, with industry employment reaching an all-time high, accounting for more than $6 billion in payroll and more than 1,000 drug candidates in development. Coughlin also presented Senate President Therese Murray with the MassBio Legislator of the Year Award for her efforts to foster innovation, forge global partnerships and enhance patient access.

“We need to keep working, building on the foundation we’ve put in place, and we have to continue to market the Commonwealth,” said Murray, who recently created the Northern Ireland Massachusetts Connection (NIMAC), a group dedicated to advancing business, research and clinical collaboration among Massachusetts, Northern Ireland and Europe.

“One thing is clear,” Murray continued. “Small connections make a very big impact. I’m committed to making these connections and ensuring that Massachusetts continues to be viewed as the leader in this industry.”

Throughout her career, Murray has been a driving force behind children’s health issues and health care reform efforts, and helped pass landmark legislation including Children’s Mental Health and the Health Care Reform Act of 2006. Last legislative session, she led an effort to allow patients to take advantage of rebates and discount programs made available to companies who manufacture complex and life-changing biologics. The Senate also passed minor changes to the Sales and Marketing disclosure law—also known as the gift ban— which brought it more in line with the federal law. Furthermore, she shepherded health care cost containment legislation through the process, resulting in Chapter 224, which is now in its implementation stage.

“We applaud Senate President Murray for her commitment to patients and ensuring that all aspects of health care, including the breakthrough therapies being researched, developed and manufactured right here in Massachusetts are available to the citizens that need them most,” said Coughlin.

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