Top 10 Therapeutics

What's in our Ebook?

Mechanism of action

In our Ebook we provide an overview of the mechanism of action of each our the biologics listed and it's affect on inflammation and respose.

Repurposing

In our Ebook we provide an overview of repurposing of each biologic and associated biosimilars.

Sales

Finally, we provide an overview of sales of each biologic, it's manufacturer and the up and coming biosimilars!

What are biologics?

Biological drugs, or biologics, are commonly defined as large, complex, organic molecules (composed of sugars, proteins, or nucleic acids) produced by living organisms (either microorganisms or mammalian cells). Biologics englobe a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

In contrast to chemical drugs, whose production processes and structures are relatively well-characterized and uniform, biologics necessitate complex and costly aseptic manufacturing processes and quality controls that are more difficult to scale-up.

The first biologics

The first appearance of biologics on the pharmaceutical market dates back to the 1980s with the development of human growth hormone, insulin and red-blood cell stimulating agents.

Since then, thanks to the advances in genetics, proteomics, cellular biology and biotechnologies that allow researchers to dissect cellular pathways involved in pathological processes, biologics now represent the cutting-edge of biomedical research and the most promising line of treatment in a wide variety of medical indications, including cancers and autoimmune diseases. Noticeably, among the top 10 drugs reported in 2018 by sales, 7 can be considered bona fide biologics.

Overview

Here, we propose an overview of the Top 10 Biologics sold in 2018, based on the financial reports published by pharmaceutical companies in early 2019. Comprehensive information about each drug can be accessed through their full prescribing information.


Humira®

Generic name: Adalimumab5

Manufacturer: AbbVie Inc.

First marketing date (USA): December 2002

Sales in 2018 (USD billions): 19.9366

Product type: Humanized anti-TNF IgG1K monoclonal antibody.

Medical indication(s) (full prescribing information)7:

  • Moderate to severe rheumatoid arthritis in adults
  • Moderate to severe polyarticular juvenile idiopathic arthritis in children over 2 years old.
  • Psoriatic arthritis in adults.
  • Ankylosing spondylitis in adults.
  • Moderate to severe Crohn’s disease in adults.
  • Moderate to severe ulcerative colitis in adults.
  • Moderate to severe chronic plaque psoriasis in adults.
  • Non-infectious intermediate, posterior and pan-uveitis in adults and children over 2 years old.
  • Moderate to severe hidradenitis suppurativa in people 12 years and older.

Mechanism of action: TNFα is a pro-inflammatory cytokine whose levels are found elevated in various chronic inflammatory diseases. Humira® is a TNF inhibitor that specifically binds soluble and membrane-bound TNFα, thereby preventing this pro-inflammatory cytokine from interacting with its p55 and p75 cell surface receptors8. However, the precise mechanism(s) through which Humira® achieves its anti-inflammatory effect in the variety of clinical conditions it is prescribed for remains elusive.

Repurposing: An ongoing clinical trial (NCT03180957) sponsored by the University of Oxford aims at assessing the effect of Humira® in patients suffering from Dupuytren's disease, a painful and disabling condition, affecting roughly 4% of the general UK and US population, where fingers curl irreversibly into the palm9,10. The investigators identified TNFα as a key mediator of the cellular process that initiates and maintains disease progression.

Biosimilars approved in USA11:

  • Amjevita™ (Amgen) – September 2016
  • Cyltezo™ (Boehringer Ingelheim) - August 2017
  • Hyrimoz™ (Sandoz) - October 2018

Keytruda®

Generic name: Pembrolizumab12

Manufacturer: Merck

First marketing date (USA): 2014

Sales in 2018 (USD billions): 7.17113

Product type: Humanized anti-PD-1 IgG4 monoclonal antibody.

Medical indication(s) (full prescribing information)14:

  • Advanced non-small cell lung cancers
  • Melanoma
  • Head and neck squamous cell cancer
  • Classical Hodgkin lymphoma
  • Microsatellite instability-high cancer
  • Advanced urothelial bladder ca