IN PARTNERSHIP Recombinant human insulin – used to treat
type 1 and some cases of type 2 diabetes – was the first commercially available biologic, entering the market in 1982 following its successful production within E. coli and Saccharomyces cerevisiae cells. Since then, other biologics have emerged and are being used to treat diseases such as Crohn’s disease and psoriasis, among others. Much like conventional small drug
development, some biologics adopt a ‘one size fits all’ approach – in which a whole population is targeted using a single therapy. The true
The top ten drugs
The drugs on the list below have all exceeded the monetary definition of a ‘blockbuster’, which designates a drug as having generated more than $1bn in annual sales. Figures are based on 2018 sales data, reported by the respective manufacturers for revenues generated in 2017:
Humira: the anti-inflammatory drug Humira is not only the bestselling biologic, it is also one of the bestselling drugs worldwide. Its indications of use are rheumatoid arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. The manufacturer is AbbVie, an Abbott Laboratories spin-off, and its global sales in 2017 were $18.4bn. Its generic name is adalimumab and was launched in 2002.
Rituxan: generic name rituximab – Rituxan was developed by IDEC Pharmaceuticals under the name IDEC-C2B8. It is currently co-marketed in the US by Biogen Idec and Roche’s subsidiary, Genentech. Its indications of use are non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Manufactured and launched by Roche in 1997, its global sales in 2017 were $9.2bn.
Enbrel: developed by researchers at Immunex, Enbrel is currently co-marketed in North America by Amgen and Pfizer, by Takeda Pharmaceuticals in Japan and Wyeth in the rest of the world. Its indications are rheumatoid arthritis, plaque psoriasis and psoriatic arthritis. Enbrel was manufactured by Pfizer/ Amgen with global sales of $7.9bn in 2017.
Herceptin: generic name trastuzumab, Herceptin was developed by Genentech, now a Roche subsidiary, and UCLA’s Jonsson Comprehensive Cancer Centre. Its indications are HER2+ breast cancer. Manufactured and launched by Roche in 1998, its global sales in 2017 were $7.4bn.
Avastin: when launched in 2004, Genentech’s Avastin was one of the most expensive drugs on the market, with a $4,400 monthly cost. Its indications are breast, colorectal, kidney, non-small-cell lung, glioblastoma and ovarian cancers. Generic name bevacizumab, Avastin was manufactured by Roche and its global sales in 2017 were $7.1bn.
Remicade: generic name infliximab – Remicade was originally developed by Centocor Ortho Biotech, which is now Janssen Biotech, a Johnson & Johnson subsidiary. Its indications are rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and ulcerative colitis. Launched in 1998, its global sales in 2017 were $7.1 billion.
Lantus: developed at Sanofi-Aventis’s biotechnology research centre in Frankfurt-Höchst, Germany, Lantus’s indication of use is diabetes. Manufactured by Sanofi in 2000, with the generic name insulin glargine [rDNA origin] injection, its global sales in 2017 were $5.7bn.
Neulasta: manufactured by Amgen in 2002 – with the generic name pegfilgrastim – Neulasta’s indication or use are Neutropenia, related to cancer chemotherapy. It’s global sales in 2017 were $4.7bn.
Avonex: marketed in the US by Biogen Idec, Avonex is also marketed 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. It’s indications are multiple sclerosis (MS). Manufactured by Biogen Idec, its global sales in 2017 were $2.1bn. Launched in 1996, its generic name is interferon beta-1a.
Lucentis: developed by Genentech in 2006, Lucentis – generic name ranibizumab – is an injectable, marketed in the US by Genentech and by Novartis outside the US. It’s indication are age-related macular degeneration. Lucentis is manufactured by Roche and Novartis, with global sales in 2017 of $1.5bn.
Outsourcing in Clinical Trials Handbook | 29
opportunity lies in the ability to target diseases at an individual level,
offering a future of personalised and precise medicine.
What does this mean for clinical trial supplies? Unlike many small molecule drugs, biologics require storage and transportation at cryogenic temperatures – often 2–8°C – and suppliers need to evaluate the whole supply chain. A lorry is a mobile, cold-storage facility – and the demand for robust, accurate GPS
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