Developing Trends in the Specialty Drug Pipeline

At the Academy of Managed Care Pharmacy's Managed Care & Specialty Pharmacy Annual Meeting, held April 23-26, in Boston, Massachusetts, an overflow capacity crowd gathered for one of the meeting’s yearly highlights­: Specialty Pharmaceuticals in Development. Aimee Tharaldson, PharmD, a senior clinical consultant in Emerging Therapeutics for Express Scripts, talked about the key trends in the specialty drug market, including cancer medications, new competition, and orphan drugs.

Six specialty classes are maturing, she said, including HIV, multiple sclerosis (MS), and drugs for psoriasis, and there is a $25 billion market opportunity through 2022 as 64 drugs come off patent protection.

Likewise, there is a similar opportunity in biosimiliars, as 71 patents lose protection through 2021, creating a $54.4 billion market. There are 10 biosimiliars pending approval this year, targeting treatments for anemia, breast cancer, neutropenia, rheumatoid arthritis (RA), non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and psoriasis. But there are significant legal hurdles in the biosimiliar market, and the FDA is working on policies to open up competition. Eventually, it will lead to significant cost savings, she said.

Market share capture varies by drug, however.

“It just seems to be taking a bit a little bit longer than we would like,” Tharaldson said. In 5 years, there could be numerous biosimiliars to the immunosuppressant drug Humira—a $16 billion market, she noted.
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