Biologics are changing the ways doctors treat common conditions that have plagued people for years. They’ve 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 numbers of dedicated biologic treatments.
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.
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 top 10 biologic drugs all have exceeded the monetary definition of a “blockbuster,” meaning they’ve generated more than $1 billion in annual sales, according to 2017 sales data reported by drug manufacturers.
Humira is approved for:
Rheumatoid arthritis Plaque psoriasis Crohn’s disease Ulcerative colitis Ankylosing spondylitis Psoriatic arthritis Polyarticular juvenile idiopathic arthritis Hidradenitis suppurativa Uveitis
Manufacturer: AbbVie, an Abbott Laboratories spinoff
Global Sales in 2017: $18.4 billion
Generic name: Adalimumab
Launch date: 2002
Rituxan is approved for:
Non-Hodgkin’s lymphoma Chronic lymphocytic leukemia Rheumatoid arthritis Granulomatosis with Polyangiitis Pemphigus vulgaris
Manufacturer: Roche
Global Sales in 2017: $9.2 billion
Generic name: Rituximab
Launch date: 1997
Enbrel is approved for:
Rheumatoid arthritisPlaque psoriasisPsoriatic arthritisPolyarticular juvenile idiopathic arthritisAnkylosing spondylitis
Manufacturer: Pfizer/Amgen
Global Sales in 2017: $7.9 billion
Generic name: Etanercept
Launch date: 1998
Herceptin is approved for:
HER2+ breast cancer HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma
Manufacturer: Roche
Global Sales in 2017: $7.4 billion
Generic name: Trastuzumab
Launch date: 1998
Avastin is approved for:
Cervical cancer Hepatocellular cancer Metastatic colorectal cancer Metastatic renal cell carcinoma Epithelial ovarian, fallopian tube, or peritoneal cancer Glioblastoma Non-squamous non−small cell lung cancer
Manufacturer: Roche
Global Sales in 2017: $7.1 billion
Generic name: Bevacizumab
Launch date: 2004
Remicade is approved for:
Rheumatoid arthritisCrohn’s diseaseAnkylosing spondylitisPsoriatic arthritisPlaque psoriasisUlcerative colitis
Manufacturer: Johnson & Johnson/Merck & Co.
Global Sales in 2017: $7.1 billion
Generic name: Infliximab
Launch date: 1998
Lantus is approved for:
Diabetes
Manufacturer: Sanofi
Global Sales in 2017: $5.7 billion
Generic name: Insulin glargine [rDNA origin] injection
Launch date: 2000
Neulasta is approved for:
Neutropenia related to cancer chemotherapy Hematopoietic subsyndrome of acute radiation syndrome
Manufacturer: Amgen
Global Sales in 2017: $4.7 billion
Generic name: Pegfilgrastim
Launch date: 2002
Gemany’s Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB and CinnaGen Company cloned Interferon-beta-1α and since 2006 the drug has been sold as CinnoVex, a biosimilar, in Iran.
Avonex/Rebif is approved for:
Multiple sclerosis (MS)
Manufacturer: Biogen Idec
Global Sales in 2017: $2.1 billion
Generic name: Interferon-beta-1α
Launch date: 1996
Lucentis is approved for:
Age-related macular degeneration Macular edema following retinal vein occlusion Diabetic macular edema Diabetic retinopathy Myopic choroidal neovascularization
Manufacturer: Roche, Novartis
Global Sales in 2017: $1.5 billion
Generic name: Ranibizumab
Launch date: 2006