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

Key Data

Biosimilars

After years of discussing the potential pathway for biosimilars and many arguments both for and against, seven biosimilars are on this list. Here are some specifics:

• Two rituximab biosimilars for Rheumatoid Arthritis, one is being developed by Boehringer-Ingelheim and is in Phase III another is being developed by Pfizer and is in Phase I/II. Rituximab is known by Roche and Biogen Idec’s trade names Rituxin and MabThera and in 2012 had over 7 billion in sales.
• One adalimumab biosimilar is being developed by Boehringer-Ingelheim for Rheumatoid Arthritis. Adalimumab is also known by Abbott’s trade name Humira. Humira had sales in 2012 of over 9 billion.
• Pfizer is developing a trastuzumab biosimilar for metastatic breast cancer currently in Phase I. Trastuzumab is known by Roche’s trade name Herceptin and had sales in 2012 of over 6 billion.
• Other biosimilars on the list include an epoetin alfa biosimilar for anemia, currently in Phase III and being developed by Hospira; a recombinant factor IX biosimilar for Hemophilia B, application submitted, and being developed by Inspiration Biopharmaceuticals and Ipsen; and a somatropin biosimilar for somatropin deficiency in Phase III and being developed by LG Life Sciences.

Top Sellers Looking for Additional Indications

The list also identifies several biologic best sellers that are seeking additional indications. Last week we posted a blog listing the top selling biologics of 2012 titled “Biologics Take Top Spots in Best Selling Drugs of 2012.” Of the top eight best selling biologics from last year, five are seeking additional approvals.

• The top selling biologic pursuing the most indications is Humira. Humira is currently in Phase III studies for the following indications: rheumatoid arthritis (combination therapy), uveitis, interstitial cystitis, Crohn’s disease in children and adolescents, hidradentis suppurativa, and spondylarthritis.
• Avastin is also seeking several new indications. Avastin is currently has an application submitted for ovarian cancer, and is in Phase III 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.
• Remicade is currently in Phase III clinical studies for Crohn’s disease (prevention of relapse after surgery resection).
• Enbrel has an application submitted for plaque psoriasis in adolescents and children.
• Lantus is in Phase II clinical studies for Type 2 diabetes.

Cell Therapies Also Make a Strong Showing

Cell therapies were also well represented with 69 therapies on the list including 15 in Phase III clinical studies. Of the products in clinical trials, nine therapeutic categories were represented and include: cardiovascular disease, skin diseases, cancer and related conditions, digestive disorders, transplantation, genetic disorders, musculoskeletal disorders, eye conditions, and other.

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

For further reading see:

• The Cell Culture Dish – “Biologics Take Top Spots in Best Selling Drugs of 2012.”
• Pharmaceutical Research and Manufacturers of America report “Medicines in Development – Biologics, 2013 Report.” – Overview
• Pharmaceutical Research and Manufacturers of America report “Medicines in Development – Biologics, 2013 Report.” – Biologic Listing