Genetic Engineering News recently published an article titled “Top 20 Best Selling Drugs of 2012,” in which they laid out the top sellers for last year. Of the top twenty spots, eight were captured by biologics.
Other highlights for biologics included:
- The top three best selling drugs were biologics – Humira, Remicade and Enbrel, and all are involved in the treatment of arthritis.
- Every biologic on the list had sales that were up in 2012.
- The biggest sales increases were for Lantus (Sanofi) with an increase in sales of 19.3% and Humira (AbbVie) also up 19.3% from last year.
- Biologics to treat cancer were also at the top of the list with Roche’s Rituxin, Herceptin, and Avastin in fifth, seventh and nine place, respectively.
|Rank||Biologic||Expression System||Company||2012 Worldwide Sales in Millions||Approved Indication|
|1||Humira (adalimumab)||CHO||AbbVie||9,265||Moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn’s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis|
|2||Remicade (infliximab)||Murine Myeloma||Johnson & Johnson and Merck & Co.||8,215||Moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate; Crohn’s Disease in children 6 years and older, and adults who have not responded well to other medicines; rheumatoid arthritis; ankylosing spondylitis; psoriatic arthritis; chronic, severe, extensive, and/or disabling plaque psoriasis in adults; moderately to severely active ulcerative colitis in children 6 years and older and adults that have not responded well to other medicines|
|3||Enbrel (etanercept)||CHO||Amgen and Pfizer||7,963||Moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis|
|4||Rituxin (rituximab, MabThera)||CHO||Roche and Biogen Idec||7,285||Non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis|
|5||Lantus (insulin glargine)||E.coli||Sanofi||6,648||Once daily treatment for diabetes|
|6||Herceptin (trastuzumab)||CHO||Roche||6,397||HER2-positive breast cancer and HER2-positive metastatic gastric cancer|
|7||Avastin (bevacizumab)||CHO||Roche||6,260||Metastatic colorectal cancer (colon cancer), non–small cell lung cancer, glioblastoma & metastatic kidney|
|8||Neulasta (pegfilgrastim)||E.coli||Amgen||4,092||Neutropenia caused by cancer chemotherapy|
As shown in the table, CHO continues to be the most popular expression system for the top selling biologics with five of the eight being manufactured in CHO cells. In a previous blog “Best Selling Biologics for 2011 – CHO Still the Top Manufacturing Choice,” we discussed the manufacturing cell lines used in the top ten best selling biologics of 2011. In 2010, four out of the top five best selling biologics used CHO cells for manufacturing. In 2011, according to Huggett and Lähteenmäki (2012), seven out of the ten were manufactured using CHO cells.
While CHO cells are still the most popular expression system, there is a desire to improve on current product yield and to reduce manufacturing costs and there are running debates on how to achieve this. One possible option is to make improvements on the front end by utilizing technologies like gene synthesis to improve on traditional cloning and increase expression levels. Another option is to further optimize media, by utilizing animal-free, defined media supplements including recombinant proteins. Another option could be the use of perfusion bioreactors and single use systems to improve on the current batch-fed production system. Yet another area being explored is employing other expression systems including murine myeloma cells, plant cells, insect cells and human cells. Lastly and perhaps the most significant (in terms of paradigm shift) is the work being done on continuous processing instead of the standard batch-fed processing.
In a previous blog titled “Continuous Processing: From Cookie Preparation to Cell-based Production,” we discussed the system-wide use of continuous processing (CP) for biopharmaceutical manufacturing. In continuous processing, as the name suggests, manufacturing is conducted in one continuous process where raw materials constantly flow in and out of manufacturing equipment and are continually processed into an intermediate or final product. Continuous bioprocessing uses a smaller bioreactor continually providing product-containing media to specialized chromatography that can continuously separate the product from the surrounding liquid. Using this method, no longer requires huge bioreactors to manufacture the same amount of product, which leads to smaller overall manufacturing footprints and eliminates harvest-hold containers and massive clarification systems.
Where do you see the future of biopharmaceutical manufacturing going? Do you think we will ever reach a day when all of the top 10 best selling drugs are biologics?
Don’t miss the the latest versions of this information – “Biologics Still on Top in Best Selling Drugs of 2013” and “10 Biologics on Best Selling Drugs List for 2014.”
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