Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report titled 2013 Report: Medicines in Development – Biologics. It lists 907 biologics currently in development at “America’s biopharmaceutical research companies.” The list includes biologics targeting more than 100 diseases that either are currently in human clinical trials or are under review by the US Food and Drug Administration (FDA). Of those 907 product candidates, the most common types are monoclonal antibodies (MAbs, 338), vaccines (250), and other recombinant proteins (93). The largest therapeutic categories include cancer and related conditions (338), infectious diseases (176), and autoimmune disorders (71). It is no surprise that over half of those cancer therapies are MAb products, representing 170 of the 338 products in development.

Key Data

Biosimilars Are Moving Forward: After regulators spent years discussing a potential pathway for biosimilars — with many arguments both for and against— seven such products are on the list this year.

There are two rituximab biosimilars in development for rheumatoid arthritis. One is being developed by Boehringer-Ingelheim and is in phase 3; the other is being developed by Pfizer and is in phase 1–2. Rituximab is better known by Roche and Biogen Idec’s trade names Rituxin and MabThera. Together, they had over US$7 billion in sales for 2012.

One adalimumab biosimilar is in development at Boehringer-Ingelheim, also for rheumatoid arthritis. Under Abbott’s trade name Humira, adalimumab had 2012 sales of over $9 billion. And Pfizer is developing a trastuzumab biosimilar for metastatic breast cancer (currently in phase 1). Under Genentech/Roche’s trade name Herceptin, trastuzumab had 2012 sales of over $6 billion.

Other biosimilars on the list include an epoetin alfa biosimilar for anemia, currently in phase 3 and being developed by Hospira; a recombinant factor IX biosimilar for hemophilia B, for which Inspiration Biopharmaceuticals and Ipsen have submitted an application to the FDA; and a somatropin biosimilar for somatropin deficiency, in phase 3 under development by by LG Life Sciences.

Top Sellers Are Seeking Additional Indications: PhRMA’s list also shows several biologic best sellers for which their sponsors are looking for additional indications. Of the top eight best-selling biologics in 2012, five are up for additional approvals.

The top-selling biologic pursuing the most indications is Abbott’s adalimumab product, Humira. It is currently in phase 3 studies for the following indications: rheumatoid arthritis (combination therapy), uveitis, interstitial cystitis, Crohn’s disease in children and adolescents, hidradentis suppurativa, and spondylarthritis.

Genentech/Roche is also seeking several new indications for its bevacizumab product, Avastin. The company has submitted an application for ovarian cancer treatment and is testing this product in phase 3 trials for the following indications: HER-2–negative breast cancer, HER-2–positive breast cancer, high-risk carcinoid tumors, glioblastoma multiforme, metastatic ovarian cancer, and non–small-cell lung cancer.

Janssen Biotech’s infliximab product, Remicade, is currently in phase 3 clinical studies for Crohn’s disease (prevention of relapse after surgery resection). Amgen has submitted an application for its etanercept product, Enbrel, to treat plaque psoriasis in adolescents and children. And Lantus insulin glargine for type 2 diabetes from Sanofi Aventis is in phase 2 clinical studies.

Cell Therapies Also Make a Strong Showing: Cell therapies (including stem-cell therapies) are also well represented this year, with 69 development projects on the list — 15 of them in phase 3 clinical trials. Nine therapeutic categories were represented on the list: cardiovascular disease, skin diseases, cancer and related conditions, digestive disorders, transplantation, genetic disorders, musculoskeletal disorders, eye conditions, and “other.”

Racing to the Top

Not all these biologics will receive FDA approval, but the list indicates a strong group of candidate biologics moving forward through the regulatory process. This further strengthens the progress that biologics have made toward taking top spots in drug sales. The PhRMA report states, “Over the past decade, biologics have accounted for one-third of new medicine approvals.” They also account for eight of the top 20 drugs by worldwide sales in 2012 — and those eight include the top three best-selling drugs Humira, Remicade, and Enbrel.

About the Author

Author Details
Brandy Sargent is editor and frequent author of the Cell Culture Dish blog; 1-916-708-5273; [email protected]; www.cellculturedish.com. This article is adapted from the 21 March 2013 blog entry.

REFERENCES

1.) Sargent, B. 2013.. Biologics Take Top Spots in Best Selling Drugs of 2012.

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