NeuAge Institute (NAI)

Biosimilars: A Guide for Those in Pharmaceutical Regulatory Affairs

If you’re thinking about a career in pharmaceutical regulatory affairs, you’ll need to stay up to date with the latest products and developments on the market. Biosimilars are a fairly recent innovation in the pharmaceutical industry–and one with huge potential. The first biosimilar was approved by the FDA in 2015, and in the last two years, developments and approvals have accelerated. 

A biosimilar is a biological medical product that is almost identical to an original product that has already been manufactured for sale. Biosimilars are versions of an existing product that have been carefully tested and approved for release by the FDA. If you want to learn more about the properties, purpose, and regulatory requirements of biosimilars, read on for a brief guide. 

What Makes Biosimilars Different from Generic Drugs? 

To understand biosimilars, you first need to understand what biologics are–the original product that biosimilars are replicating. Biologics are medications that are made from living cells, such as animal cells, bacteria or yeast. While biosimilars cannot be exact copies of these medications, they still contain the same active ingredient and function in the same way.

Generic drugs, on the other hand, are copies of synthetic drugs, meaning they’re made from a chemical process. Generic drugs are exact replicas of the original synthetic drug. However, because biosimilars are copies of complex living cells, it’s impossible for them to be exact replicas.  

Since biosimilars are made from living organisms and don’t contain identical ingredients, the testing process is far more extensive than for generic drugs, leading to higher costs for the pharmaceutical industry.  

Biosimilars are replicas of biologics, while generic drugs are synthetic.

Development & Approval of Biosimilars

All biosimilars must undergo an evaluation process to ensure the quality, efficacy, and safety of the product for patient use. But remember, a biosimilar is highly similar to an existing FDA-approved product in terms of its safety and efficacy. In that case, the goal of pharmaceutical regulatory affairs is to determine a match between the new biosimilar and the original product. Data is collected to prove similarity and to show that there are no meaningful clinical differences between the two products. There’s no need to test the biosimilar as a new, independent product, so the process is not as rigorous. Nonetheless, they are carefully reviewed by the FDA and monitored on an ongoing basis. 

Students in the Regulatory Affairs program at NeuAge Institute will explore the U.S. FDA regulatory framework with courses that cover the submission and compliance laws around biosimilars. 

Biosimilars are tested to demonstrate their match with an original biologic.

The Future of Biosimilars for Those in Pharmaceutical Regulatory Affairs

The main purpose of biosimilars is to reduce the healthcare costs around the use of biologics. Biologic drugs are very expensive to produce and use. Biosimilars offer a quicker path to market approval, providing the public with improved access to effective biological products. Biosimilars are also sold at a lower price than the original biologics, saving the healthcare system money, which can then be allocated to new treatments. With a path that provides more treatment options and better access to lifesaving medication, we can expect biosimilars to take off in future years. 

By training at NeuAge Institute, you can position yourself at the forefront of cutting-edge advancements in the pharmaceutical industry. 


Are you interested in learning more through regulatory affairs courses?

Contact NeuAge Institute today!




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