The year's Top Drugs
According to the IMS report, spending on diabetes medications also increased by 8.2% on a net basis in 2015, compared with 30.1% growth on an invoice basis. Insulins accounted for nearly half of the $10 billion invoice price growth; however, all of the increase was offset by rebates and price concessions. Additionally, invoice spending on DPP-IV inhibitors, SGLT2s, and GLP-1 agonists rose steadily.
Several new active substances (NAS) and non-NAS were also unleashed. NAS refers to a new molecular entity, new biologic agent, or a new combination drug in which at least one element is new. Oncology, infection, and neurological disorders were the most prevalent therapeutic areas, and account for majority of NAS launches in recent years. About a third of the NAS launched in 2015 had a FDA orphan designation, while the number of non-orphan drugs approvals was at its highest since tracking began in 2002. Approximately two-thirds of all orphan drugs were for oncology indications, while the rest targeted rare diseases, such as cystic fibrosis and hemophilia B.
Prominent non-NAS launches include rare disease treatments, and options offering improvements that address patient adherence and unmet needs. Five additional therapies for diabetic patients are now available, including the first inhaled insulin and options providing easier insulin administration. New HIV treatments were also unveiled, providing options against drug resistance and reduced pill burden.
The IMS report revealed that developments in biosimilars remain at high levels, with its first U.S. approval in 2015 and a growing pipeline on the horizon. Sandoz launched Zarxio (filgrastim-sndz), the first biosimilar approved via the biosimilar pathway, in August 2015. The first non-original biologics, Granix and Omnitrope, were previously approved through alternative FDA pathways. According to Ralph Boccia,MD, Medical Director of the Center for Cancer and Blood Disorders, and Chief Medical Officer for the International Oncology Network (ION), “while biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general. Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies.” Seven biosimilar applications were pending via the FDA biosimilar pathway at the end of 2015, and others with The Prescription Drug User Fee Act (PDUFA) dates in 2016.
Pipeline Drugs and Future predictions
In November 2016, Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the FDA for MYL-1410, the proposed biosimilar to traztuzumab (Herceptin, Genentech).
The investigational quinolone antibiotic, delafloxacin (Baxdela, Melinta Therapeutics), is being evaluated for the treatment of skin infections and community-acquired bacterial pneumonia. The drug has broad-spectrum activity, most notably against MRSA. Key advantages of the drug include no dose adjustment or monitoring requirements in obese patients, according to a phase 3 study presented at IDWeek 2015 in San Diego, CA.
Genentech’s anti PD-L1 cancer immunotherapy, Tecentriq (atezolizumab), received FDA approval for bladder cancer recently, and is set to be one of the best selling drugs in 2022, according to a report released by EvaluatePharma. Roche’s multiple sclerosis therapy, Ocrevus, and hemophilia drug, emicizumab, are projected to be potential blockbusters and have helped the pharma company claim the crown for the highest valued pipeline.
Monica Shah, PharmD is a Clinical Pharmacist at RWJ Barnabas Health in New Jersey and adjunct faculty member at Ernest Mario School of Pharmacy at Rutgers University.