Key Specialty Pharmaceutical Market Trends

In a session at AMCP's 27th Annual Meeting & Expo, held April 7-10 in San Diego, that was so popular that attendees were being directed to an overflow room, Aimee Tharaldson, PharmD, senior clinical consultant in emerging therapeutics at Express Scripts, highlighted specialty pharmaceuticals that are currently in development and expected to come to the market in the next few years.

The key specialty market trends she highlighted were increased competition, orphan drug development, and breakthrough therapies. Through 2019, 30 specialty drug products have patent expirations, which represents a $14.1 billion specialty generic drug opportunity. In addition, there is a $39.1 billion biosimilar opportunity with 54 biologic products losing patent protections through 2020. In 2015 alone Neulasta, Rituxan, Epogen, Procrit, Neupogen, Synagis, and Pulmozyme all have patent expirations.

“Of course, it’s important to remember that just because they may have a patent expiration at that time does not necessarily mean we will see a biosimilar approved at that time,” she said. “There are still a lot of issues that need to be resolved, including litigation.”

Biosimilar Update

Reference biologics are given 12 years of patent protection. In addition, biosimilars cannot be submitted for another 4 years after that.

Zarxio (filgrastim) from Sandoz, biosimilar to Neupogen by Amgen, was the first biosimilar approved by the FDA for use in the United States. A number of other biosimilars have expected approval dates in 2015: Inflectra (infliximab) from Celltrion and Hospira (June 8); a pegfilgrastim biosimilar from Apotex (August 17); Grastofil (filgrastim) from Apotex (October 13); and Retacrit (epoetin alfa) from Hospira (October 16).

Initially, biosimilars will act as competing brands, according Dr Tharaldson. She expects they will be priced at a 20% discount of the branded products, but the cost to develop and market, plus pay patent attorneys will add up.

Specialty Pipeline: Cancer Drugs

More than one-third of the specialty pipeline is in development for cancer medications, and half of those are administered orally, Dr Tharaldson said.

The market is seeing more breakthrough therapies as well as continuing development of targeted therapies and immunotherapies. The latter of which is expected to treat half of cancer in the next 10 years, she added.

Specialty Pipeline: Hepatitis C

There are now all oral options available for the 3.2 million Americans with hepatitis C: Harvoni, Viekira Pak, Sovaldi, and Olysio. The standard of care for hepatitis C is evolving rapidly with guidelines being updated frequently, Dr Tharaldson said.

In addition, based on the drugs in the pipeline, there will be more oral interferon-free regimens hitting the market, but also more drugs able to treat all genotypes and shorter treatment durations.

Just that morning, Merck had received breakthrough status for grazoprevir/elbasvir, a single once-daily tablet for the treatment of genotype 1. The company is also developing grazoprevir/elbasavir with MK-3682, which would treat genotypes 1-6, although approval isn’t expected until 2018. Other drugs being developed to treat all genotypes are Gilead’s GS-5816/Sovaldi (approval in 2016); Achillion’s ACH-3102/ACH-3422 (approval in 2017); and AbbVie’s ABT-493/ABT-530 (approval in 2018).

Specialty Pipeline: Hypercholesterolemia

The 71 million Americans with high LDL-cholesterol are typically treated with statins, but 10 million patients have statin intolerance or do not reach their LDL-cholesterol goal.

There are 2 PCSK9 inhibitors expected to be approved this summer: Praluent from Sanofi/Regeneron (July 24) and Repatha from Amgen (August 27).

“This is going to be the most important area to keep an eye on this year,” Dr Tharaldson said.