Gallery

The Difference Between Biosimilar and Generic Drugs: The key is that Biosimilarity does not mean Bioequivalence!

The difference between Biosimilarity and Generic drugs is an important, but easily misunderstood difference. Biosimilar drugs are generally from human or animal microorganisms that are biologics. The Biosimilar drugs or products are not generics of branded or patented drugs. The Biosimilar products were passed and allowed under the Biologicals Price Competition and Innovation Act (BCPI) of 2009.

The Biosimilar products are not bioequivalent to a branded or patented drugs. The biosimilar products were thought to provide low cost alternatives to expensive branded or patented biologics, but this has not necessarily been the result. The Biosimilar products are generally larger molecules and do not have the same chemical structure as the reference or branded product. The Biosimilar products are supposed to have the same mechanism of action and supposed to have the same clinical safety and effectiveness as the reference or branded product.

Biosimilar products typically, retail for 15-35% less than the branded reference or patented product. Generics, typically, retail for 80-90% less than the branded or patented drugs. Keep in mind that Generics have the same active ingredient, strength, safety, route of administration, quality, performance characteristics, and intended use.  However, Biosimilar products have had a more difficult time becoming a reliable alternative to the branded or predominant biologic.  Perhaps, the price difference is not significant, perhaps some branded or predominant biologics are more entrenched due to other factors.

For example, Pfizer recently sued Johnson and Johnson (J&J) claiming antitrust violations stemming from J&J’s contracts with insurers that require the use of Remicade first.  Essentially, the insurance company will only provide coverage for Remicade not Pfizer’s Biosimilar product Inflectra.  Thus, many hospitals and health care providers do not even keep Inflectra on stock, b/c insurance will not cover it.  These biologics are supposed to treat Rheumatoid arthritis and Crohn’s disease.  However, Pfizer claims that J&J still has 96% of the market for these biologics despite the availability of Inflectra.

It is not clear if these Biosimilar biologics will have the same effect and benefit to consumers and patients as generics, but the change required may be treating Biosimilar products as insured alternatives.  Generics are normally treated as insured alternatives to branded or patented drugs.  Also, perhaps, the price for the Biosimilar products may have to come down more than 15-35% to gain more commercial acceptance.   Just remember a Generics are not the same as Biosimilar products!  For more go to http://www.businessinsider.com/pfizer-sues-johnson-and-johnson-over-remicade-biosimilar-anticompetitive-2017-9 or go to https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241718.htm

 

Leave a Reply

Please log in using one of these methods to post your comment:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s