Forecasts from AMCP's annual meeting indicate a full pipeline for specialty medications.
Approximately $35 billion in brand-name biologics are expected to lose patent protection by 2019. Forecasted at her last talk on this topic in October 2011, Dr Tharaldson noted that biosimilar agents are now coming to market.
Furthermore, FDA has since published draft guidance on biosimilars, to assist manufacturers in bringing these agents to market, and has said that it will work with manufacturers throughout the process.
In addition to more oral agents for RA, MS, and HCV, other specialty agents to treat inflammatory conditions such as psoriasis, systemic lupus erythematosus, and gout, also are on the horizon.
Potential blockbuster tofacitinib (Pfizer), an oral JAK inhibitor for the treatment of moderate-to-severe active RA, is expected to be approved this year, according to Dr Tharaldson. It will be competing with injectable tumor necrosis factor (TNF) inhibitors etanercept (Enbrel, Amgen and Pfizer) and adalimumab (Humira, Abbott).
Relapsing remitting multiple sclerosis (RRMS) is another area that will bring new treatment options to the market. One example is oral MS candidate BG-12 (Biogen Idec), which likely will be the most significant specialty medication approved this year. "BG-12 is an oral, twice-daily medication that has the potential to be used as a first-line agent, and develop blockbuster status," said Dr Tharaldson.
There is also hope in the coming years of a treatment for secondary-progressive multiple sclerosis (SPMS), which currently has no FDA-approved therapy. SPMS is primarily considered a progressive disease course because it marks the transition from the inflammatory process that occurs in RRMS to a process characterized by gradual destruction and loss of nerve fibers. Of the 85 % of people initially diagnosed with RRMS, approximately half will transition to SPMS within 10 years, and 90% will transition within 25 years.
As for HCV, more direct-acting, oral antivirals with different mechanisms of action will become available in the next 3 years, and within a few years, an all-oral regimen will be used to treat HCV, similar to how HIV is now treated. The HIV market will likely see Gilead Sciences' once-daily "quad" tablet which combines emtricitabine/tenofovir (Truvada) with elvitegravir (a novel integrase inhibitor) and cobicstat (booster agent).