Biologics vs Biosimilars – which one to choose?

Biologics vs Biosimilars – which one to choose?

If you are a pharmacist or a student studying pharmacy then you must have heard the terms Biologics and Biosimilars. They are some of the leading medications to treat diseases, which are very difficult to cure.

Biologics are drugs that are curated out of materials coming from living organisms. Research and development have led to various discoveries and thanks to modern biotechnology, solutions have been found to extract living cells from animals, humans or other micro-organisms and derive medications to treat specific conditions. Biologics comprises of various insulins, special medicines and vaccines. These are highly expensive and are available at certain pharmacies. Moreover, sometimes insurance doesn't cover them until the user has tries less expensive medications. Some examples of biologics are Humira, Enbrel, Orencia, Neupogen, Remicade, Shingles vaccine and others.

Biologics are highly different from regular drugs as they have large and highly complex molecules, which are developed using genetically engineered cells. Thus, each molecule of a biologic is different from the other.

On the other hand, Biosimilars is exactly what its name implies. The complex nature of biologics makes it difficult to copy. As the originating living cells are unique, making a drug in the exact same way is beyond impossible. Thus, biosimilars came into being. They are the products that have a similar function, safety, effectiveness and structure as biologics but are not interchangeable with the later. Some examples of Biosimilars include Zarxio (Neupogen), Fulphila (Neulasta), Inflectra (Remicade), and others.

Biologics Biosimilars
Novel therapeutic Competitive bioequivalence
Almost 15 years to develop Almost 8-9 years to develop
$1.2 billion cost $100-200 million cost
Patentable Non-patentable
Reference Price Reduced Price

Here are the differences between Biologics and Biosimilars –

Why pick Biosimilars over Biologics?
Both are speciality drugs and one have to pay higher insurance rates for coverage. However, Biosimilars are almost 27% cheaper than their Biologics counterparts. The difference in this price is because of the approval path, which is cheaper and lesser. While Biologics manufacturers take a lot of clinical trials and development time, Biosimilars take less amount of research, clinical trials and development time. However, this doesn't make Biosimilars less effective.

What do Biologics and Biosimilars treat?

  • • Arthritis
  • • Cancers
  • • Autoimmune diseases, like multiple sclerosis
  • • Inflammatory diseases like Crohn’s disease or ulcerative colitis
  • • Pulmonary arterial hypertension
  • • Osteoporosis
  • • Hepatitis B and C

According to the reports of National Center for Biotechnology Information, 'India has a thriving biosimilar ecosystem in comparison to other countries and because of that Indian pharmaceutical companies have risen as the global market leaders in biosimilars. India approved its first biosimilar much before the United States and Europe. The first biosimilar was approved and marketed in India in 2000 for hepatitis B, although no specific guideline was available at that time for the development and marketing of biosimilar in India. India developed its new guidelines in 2012 for pre- and post-marketing approval of similar biologics.'

The global Biosimilars market is expected to reach $35.7 billion by the end of 2025 at a CAGR of 24.7%.