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What's All the Noise About?

By Spondylitis Association of America

This article originally appeared in the Summer 2016 issue of Spondylitis Plus, the quarterly news magazine of Spondylitis Association of America. Members receive every copy of Spondylitis Plus in the mail for free.

The biologic drug landscape shifted in March 2015 when The Food and Drug Administration approved the first of a new subclass of treatments to be marketed in the United States—biosimilars.  Recently, a second biosimilar product—Inflectra (infliximab-dyyb)—a biologic drug similar to Remicade® (infliximab) was approved. Their introduction may help expand access to high-quality treatment options for clinicians and patients and may reduce costs to families, caregivers, payers, and the healthcare system.

It has been recognized that the most effective treatments for some of the most difficult diseases in the U.S. are biologic medicines; more so, it has been reported that the introduction of biosimilars is expected to help lower cost burdens for the U.S. healthcare system. It also promises to provide earlier, more consistent access to these important medicines for patients with cancer, ankylosing spondylitis, multiple sclerosis, rheumatoid arthritis, inflammatory bowel diseases such as Crohn’s, and more.

What are biologics?

To understand the potential implications of biosimilars, both in the marketplace and in patients’ lives, it may be helpful to understand the nature of biologic drugs. Many of today’s important medications are biological products. Biological products are made from living organisms. The material they are made from can come from many sources, including humans, animals, and microorganisms such as bacteria or yeast. Biological products are manufactured through biotechnology, derived from natural sources, or, in some cases, produced synthetically. And, biosimilars are just what the word implies: similar. A biosimilar is a type of biologic that is highly similar to another branded product. It has also been called a copycat version.

Biologics are different from conventional medications. Conventional medications—compounds—are generally made from chemicals, or are chemically synthesized. Hence, their structure can be relatively easily defined and copied. Biologics, on the other hand, are many times more complex to produce than conventional drugs.

Conventional drugs are called small-molecule drugs, while biologic drugs are called large-molecule drugs. This is due to the fact that biologics are made up of big and complex molecules, often 200 to 1,000 times the size of more common small-molecule drugs. For example, aspirin, a small-molecule drug, is made up of only 21 atoms. While one of the earlier, well established biologics, which is used to treat ankylosing spondylitis and psoriatic arthritis, consists of more than 20,000 atoms.

Don't call them generics

Branded drugs fall into two basic categories: small-molecule drugs, which are usually made through chemical synthesis – breaking and reforming chemical bonds and biologics, which are proteins made in living cells, grown in incubators, and purified from the cells, hence being substantially more complex.

Will there be cost savings?

There has been much noise suggesting that huge savings may be realized for the consumer with biosimilars vs. biologics. However, this may not be evident right away. When the first biosimilar, a white blood cell booster, came to market, it launched at just 15% lower than the brand name drug. If other biosimilar manufacturers follow this lead, discounts might not be that great, at least at first. It has been explained that this may in part be due to the fact that the spending on larger clinical trials and marketing, combined with higher manufacturing costs for biosimilars compared to generic compounds, means that biosimilars can't be sold for similarly deeply reduced prices of small-molecule generics, which often go for 10% or less of the branded-drug price. In spite of the data available today, industry analysts have estimated a cost savings for U.S. patients and payers in the amount of $5.7 billion between 2014 and 2024 in the case of the first biosimilar approved by the FDA. These same individuals across the investment industry are also projecting additional drugs in the biosimilar pipeline could save an estimated $250 billion over the course of the next 10 years. That said, industry observers are reporting that for the time being, biosimilars likely will be priced closer to the price of the brand-name drug.

Patent protections

The opportunities for biosimilars are huge for both manufacturers and consumers. It is known that many leading biologic medicines, worth more than $81 billion in global annual sales, are scheduled to lose their patent protections by 2020.

What is the approval process for biosimilars and are they safe?

Biosimilars are licensed (approved) by the FDA when they are proven to be highly similar to an already FDA-approved biological product, known as the biological reference product, and have been shown to have no clinically meaningful differences from the reference product. Minor differences in clinically inactive components are allowed, but there must be no clinically meaningful differences between the biosimilar and the reference product it was compared to in terms of the safety, purity, and potency of the product.

It is important to underscore that the goal of the current FDA approval pathway for biosimilars is to demonstrate biosimilarity between the proposed product and the reference (brand) product, but not to independently establish safety and effectiveness of the proposed biosimilar product.

The FDA reports rigorous standards in their approval process that include:

  • Analytical studies demonstrating that the biological product is “highly similar” to the brand product except for potential minor differences in inactive components
  • Animal studies (including the assessment of toxicity)
  • A clinical study or studies that are described as sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the brand product is licensed.

Perhaps an additional thought regarding safety might be to consider that some of the biosimilars not yet available on the U.S. market, have been available in Europe for many years beginning in 2009, providing us with real-life patient experience with these drugs.

Background Check

So how exactly did all of this come about? The Patient Protection and Affordable Care Act, signed into law March 23, 2010, amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to an FDA-licensed (approved) biological product. This pathway is provided in the section of the Affordable Care Act known as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)—thus setting the stage for the introduction of biosimilars to the U.S. marketplace.

Types of biologics used for arthritis

Tumor necrosis factor (TNF) inhibitors, which target an inflammation-provoking protein made by white blood cells. (E.g. infliximab)

B-cell inhibitors, which interfere with the production of certain antibodies that are overproduced in some diseases. (E.g. rituximab)

Interleukin (IL) inhibitors, which target proteins involved in inflammation, including IL-1, IL-6, IL-12, and IL-23. (E.g. secukinumab)

Selective co-stimulation modulators, which interfere with the activation of white blood cells called T cells, thereby preventing the immune system reactions that result in inflammation. (E.g. abatacept)

Did you know?

For several years SAA has been an active member of a biosimilar watchdog coalition, Patients for Biologics Safety & Access, working with other like-minded organization to ensure patient safety is observed by the FDA as the biosimilar approval rules evolve. One example of the fruit of our work is the unique four letter suffix associated with the name of biosimilar drugs. This code identifies the drug as a biosimilar vs. the original plan to have the biosimilars carry the same exact name as the brand. The coalition observed that from a patient and prescribing physician perspective, tracking was necessary to ensure patient safety.

A second issue we are currently working on is ensuring that patients who are doing well on a brand name biologic are not forced to switch to the biosimilar version for cost savings. These medications, though highly similar, are not always interchangeable, and we firmly believe that the patient and their physician should be the only ones making medication decisions.

We will keep you posted.


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