Top 10 Biologic Drugs in the United States

These Drugs Are Changing the Way Illnesses Are Treated

Biologics are drugs made from complex molecules manufactured using living microorganisms, plants, or animal cells.  Many biologics are produced using recombinant DNA technology. They are sometimes referred to as biopharmaceuticals or biological drugs.

Biologics have revolutionized the treatment of many serious and chronic illnesses and have nudged traditional small-molecule drugs out of the top sales slots. Rheumatoid arthritis, certain cancers, and diabetes have the greatest number of dedicated biologic treatments. Biologics are changing the ways doctors treat common conditions that have plagued individuals for years.

Generic Biologics

While most drugs are chemicals synthesized from other chemicals, biologics are much more expensive due to their complex manufacturing process. Because of their high cost, there is a great demand for generic versions of biologic medications, particularly the ten listed below. Several pharmaceutical companies are lobbying for the right to manufacture generic versions. However, because they are so difficult to manufacture, there are concerns about the ability to manufacture generics both safely and reliably. 

Top 10 Biologics

The ten drugs listed below have all greatly exceeded the monetary definition of a "blockbuster" which designates a drug as having generated more than $1 billion in annual sales.  

In 2015, biologics began facing competition from biosimilars, or biogenerics, when Rituximab was developed by IDEC Pharmaceuticals under the name IDEC-C2B8.[1] The U.S. patent was issued in 1998 and expired in 2015. Humira lost its patent protection in 2016 and Remicade will lose its protections in 2018.  

The figures below are for the last available dates offered for each product.

 

1
Humira

Woman rubbing hands
Jose Luis Pelaez Inc/Blend Images/Getty Images

The anti-inflammatory drug Humira was not only the best-selling biologic; it was the best-selling drug worldwide, regardless of class. 

Indications: Rheumatoid arthritis, plaque psoriasis, Crohn's disease,  ulcerative colitis, ankylosing spondylitis; psoriatic arthritis, polyarticular juvenile idiopathic arthritis

Manufacturer: AbbVie, an Abbott Laboratories spin-off

Global Sales in 2015: $14 billion

Generic name: Adalimumab

Launch date: 2002 More

2
Remicade

Woman's skin being examined at doctor
BURGER/PHANIE/Canopy/Getty Images

Remicade was originally developed by Centocor Ortho Biotech, which is now Janssen Biotech, a Johnson & Johnson subsidiary.

Indications: Rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, ulcerative colitis

Manufacturer: Johnson & Johnson/Merck & Co.

Global Sales in 2015: $5.78 billion

Generic name: Infliximab

Launch date: 1998 More

3
Rituxan

Patient in hospital
BURGER/PHANIE/Canopy/Getty Images

Rituxan (rituximab) was developed by IDEC Pharmaceuticals under the name IDEC-C2B8. Rituxan is currently co-marketed in the United States by Biogen Idec and Roche subsidiary Genentech.

Indication: Non-Hodgkins lymphoma, chronic lymphocytic leukemia,  rheumatoid arthritis

Manufacturer: Roche

Global Sales in 2015: $7.32 billion

Generic name: Rituximab

Launch date: 1997 More

4
Enbrel

Doctor examining woman's hands
DAM GAULT/SPL/Science Photo Library/Getty Images

Etanercept was developed by researchers at Immunex. Today the drug is co-marketed in North America by Amgen and Pfizer, by Takeda Pharmaceuticals in Japan and by Wyeth in the rest of the world.

Indication: Rheumatoid arthritis, plaque psoriasis, psoriatic arthritis

Manufacturer: Pfizer/Amgen

Global Sales in 2016: $23 billion

Generic name: Etanercept

Launch date: 1998 More

5
Lantus

Mom helping son test blood sugar
Tom Merton/Caiaimage/Getty Images

Lantus was developed at Sanofi-Aventis's biotechnology research center in Frankfurt-Höchst, Germany.

Indication: Diabetes

Manufacturer: Sanofi

Global Sales in 2015: $6.98 billion

Generic name: Insulin glargine [rDNA origin] injection

Launch date: 2000 More

6
Avastin

Woman getting a mamogram
Echo/Cultura/Getty Images

When launched in 2004, Genentech's Avastin was one of the most expensive drugs on the market, with a $4,400 monthly price tag.

Indication: Breast, colorectal, kidney, non-small-cell lung, glioblastoma, ovarian cancers

Manufacturer: Roche

Global Sales in 2015: $6.95 billion

Generic name: Bevacizumab

 Launch date: 2004 More

7
Herceptin

Woman receiving mammogram
Echo/Cultura/Getty Images

Herceptin was developed by Genentech, now a Roche subsidiary, and the University of Californa-Los Angeles' Jonsson Comprehensive Cancer Center.

Indication:  HER2+ breast cancer

Manufacturer: Roche

Global Sales in 2015: $6.59 billion

Generic name: Trastuzumab

 Launch date: 1998 More

8
Neulasta

Chemotherapy
Mark Harmel/The Image Bank/Getty Images

Indication: Neutropenia related to cancer chemotherapy

Manufacturer: Amgen

Global Sales in 2016: $4.6 billion

Generic name: Pegfilgrastim

Launch date: 2002 More

9
Lucentis

Eye doctor and patient
Portra Images/DigitalVision/Getty Images

Developed by Genentech, ranibizumab, an injectable, is marketed in the United States by Genentech and by Novartis outside the U.S.

Indication: Age-related macular degeneration

Manufacturer: Roche, Novartis

Global Sales in 2015: $4.2 billion

Generic name: Ranibizumab

Launch date: 2006 More

10
Avonex

Nurse feeding patient
Peter Dazeley/Photographer's Choice/Getty Images

Avonex is marketed in the United States by Biogen Idec and by Merck under the brand name Rebif.

Gemany's Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB and CinnaGen Company cloned Interferon beta-1a and since 2006 the drug has been sold as CinnoVex, a biosimilar, in Iran.

Indication: Multiple sclerosis (MS)

Manufacturer: Biogen Idec

Global Sales in 2014: $3 billion

Generic name: Interferon beta-1a

Launch date: 1996 More

Promising biologics in the pipeline:

There are many more biologic medications on the horizon, including drugs to treat melanoma and other cancers. Sanofi and Regeneronhave partnered to develop Alirocumab, a monoclonal antibody for treating hypercholesterolemia. Janssen has received the FDA's "breakthrough" therapy designation for development of its multiple myeloma treatment, Daratumumab, a monoclonal antibody. Merck has also received breakthrough therapy designation by the FDA for MK-3475, a monoclonal antibody, intended for advanced melanoma and other cancers.