Ashok Pinnamaraju's profile

Biologic Drugs and Their Biosimilar Counterparts

Based in Roanoke, Virginia, Ashok Pinnamaraju is an experienced pharmacist who provides in-person and online prescription fulfillment services. Customer focused, Ashok Pinnamaraju provides knowledgeable advice to common questions about medical conditions and appropriate remedies. 

A recent Specialty Pharmacy Times article explored the world of biologics and the reason why there are no exact generic counterparts. With generics such as ibuprofen providing a cost effective alternative to branded drugs for relatively straightforward conditions, many patients with more complex uses such as diabetes or hypertension may seek out generic alternatives to expensive prescriptions.

Unfortunately, many of these expensive medications are biologics, which involve the combination of numerous molecules and proteins through an intensive biotechnological process. The compounds are time and resource-consuming to create and often sensitive to temperature and other external conditions. 

Instead of generics, what has evolved for biologics is non-molecularly identical biosimilars, which mimic biologics and are of a similar purity, potency, and safety level. This does not mean that biosimilars are always interchangeable with biologics, given the complexity of the production process. 

To resolve this issue, the FDA is in the process of releasing guidelines that will allow a select number of biosimilars, which have similar long term efficacy and risk profiles, to be classified as interchangeable and thus accessible under the same prescription.
Biologic Drugs and Their Biosimilar Counterparts
Published:

Biologic Drugs and Their Biosimilar Counterparts

Published: