What Are Biosimilars?

Biosimilar medications may some day be able to treat even the most serious diseases. If you've never heard of biosimilars, or if you've heard of them but you're not quite sure what they are, you're not alone. Biosimilars are a relatively recent development in the pharmaceutical industry, but they are poised to be at the forefront of pharma technology.

In the simplest terms, biosimilars are similar, but not exact, replicas of biologic drugs. Biologic drugs have been used to treat everything from rheumatoid arthritis to breast cancer.

While effective, these biologic drug treatments can be extremely expensive. FDA regulations allow these drugs to be made from a number of sources, including human or animal cell tissue, proteins, or sugars.

Frequently Asked Questions About Biosimilars

Before we delve further into the world of biosimilars, it's important to get a few basic facts out of the way. The following are all common questions we've received about biosimilars:

For starters, why haven't I heard of biosimilars before?

If you're currently living in America, that might be the primary reason that you haven't heard of this new trend in the pharmaceutical industry. They have been slow to hit U.S. shores, but have already been making a big splash in Europe.

Are biosimilars just another name for generic medication?

No. To be clear, biosimilars are not the same as generic drugs. While most drugs are comprised of chemicals and have a relatively easy-to-replicate structure, biologic drugs are more complex.

How do these differences affect the FDA's regulation of Biosimilars?

Because biosimilars are made from a variety of materials, including living cells, the FDA allows a certain amount of difference to exist in these medications. A provision of the Affordable Care Act gave the FDA the authority to approve these products.

What are the efficacy requirements and manufacturing guidelines for biosimilars?

Biosimilar products are only approved if they function in the same way as the biologic drug that it emulates. It also must be administered in the same fashion, and given in the same doses. Manufacturing sites also must meet current sanitary standards.

Will the price difference be comparable to Generic Medication?

Unfortunately, even the most generous estimates don't expect biosimilars to offer the cost reduction of a generic drug vs. a name-brand medication. While generics can cut medication costs by up to 75 or 80%, biosimilars are currently projected to be between 20-30% less expensive than biologics.

What other benefits might biosimilars bring?

In addition to lowering prices, the availability of biosimilars is expected to increase access for these once-exclusive drugs into underserved areas.

The Future Implications of Biosimilar Drugs

Over time, it is the general hope of the medical community that widely available biosimilars will reduce the overall cost of these much-needed medications. The lower research costs logged by biosimilar companies confirms that this could indeed be a possibility.

Efficacy: Are Biosimilars Really as Good as Biologics?

As we briefly touched on in the FAQ section, biosimilar manufacturers are required by the FDA to show that there are no differences between their product and the bioligic drug that they are "replicating" in the areas of:

  • Safety
  • Efficacy
  • Common Side Effects

Some in the scientific community are concerned that because the molecules in a biosimilar will not be identical to the original, that biosimilars may necessarily have unanticipated effects over time. 

The biosimilar industry is still taking shape, however; current regulations are subject to change, especially as the FDA is even now discussing regulations on biosimilar product names and marketing.

Biosimilar Production: How Long Until It's "Mainstream"?

Biosimilars could potentially be the start of an exciting and promising new era in the field of medicine. The implications of the coming wave of biosimilar medications (namely, lower cost and wider availability) could well prove to be a boom for both manufacturers and consumers alike.