Academy of Managed Care Pharmacy: Specialty drug approvals trend upward; biobetters gain momentum

Key Points

Within the next 5 years approximately $100 billion will be lost on previous blockbuster brands that will lose (or lost) patent protection. For manufacturers to enhance their return on investment, they are refocusing on researching and marketing specialty drugs, according to a specialty pharmaceuticals pipeline update at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase, Minneapolis.

There is an upward trend of specialty drug approvals, including those that are shifting for use as the mainstays of treatment. In the last 3 years, specialty approvals have increased from 8 in 2008 to 17 in 2010. From 2012 and beyond, approvals are expected to increase while some large pharmaceutical manufacturers have begun to partner or purchase biotech companies to enhance their product pipelines.

Other trends include research and approval of oral specialty agents with new mechanisms of action for the management of rheumatoid arthritis (RA), multiple sclerosis (MS), and hepatitis C virus (HCV) infection. There also will be more oral options for patients with moderate-to-severe and refractory disease, such as tofacitinib (RA); BG-12 or laquinimod (MS); and telaprevir or boceprevir (HCV) genotype 1. There also is a focus on creating biosimilars or "biobetters," which are modifications of biotechnology products such as better dosing, improved administration (such as from intravenous infusion to subcutaneous administration; pegylating products for every 2-week/4-week administration vs weekly administration), or more targeted therapies.

For more, go to http://formularyjournal.modernmedicine.com/specialtydrugs.