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Analyzing the Near-Term Pipeline for Specialty Drugs

Laura Joszt
The Academy of Managed Care Pharmacy Annual Meeting kicked off on March 28, 2017, in Denver, Colorado, with a look at the specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts.
The Academy of Managed Care Pharmacy Annual Meeting kicked off on March 28, 2017, in Denver, Colorado, with a look at the specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant for emerging therapeutics at Express Scripts.
 
She started the session by identifying key market trends, including increased competition from biosimilars. She quickly ran through some of the older legislation before highlighting newer changes, such as naming guidelines. The newest naming guidelines that require a random 4-letter suffix mean that Zarxio, the first biosimilar approved, will have to change its name from filgrastim-sndz to filgrastim-bflm, since “sndz” looked too much like Sandoz, and thus could not be considered random.
 
“This is going to take a lot of time and money and various stakeholders are trying to delay the implementation of naming changes,” Tharaldson said.
 
The latest regulation introduced was interchangeability draft guidance, released in January 2017, which requires studies to identify interchangeability. The manufacturers have to complete switching studies, alternating between the biosimilar and the reference product 2 or more times to ensure clinical safety and efficacy.
 
There have already been a number of biosimilars approved, but not all of them have launched yet. Erelzi, reference product Enbrel, could possibly launch in 2018, but patents might also protect Enbrel until 2029, said Tharaldson. Similarly, Amjevita, reference product Humira, has been approved, but it is unclear when the product will launch. According to Tharaldson, AbbVie contends it has 60 patents protecting Humira, which means Amjevita likely won’t reach the market until at least 2022 or 2025.
 
In addition, there are another 7 biosimilars pending approval for the year. As of this time, biosimilars that come to market are still acting more like competing brands, sometimes with a 15% discount.
 
Another key market trend is the increased cancer drug development. While there had been a drop in cancer drug approvals in 2016, with only 4 drugs approved down from 15 in 2015, Tharaldson expects to see a rebound in 2017 with 12 to 14 new drugs approved.
 
However, these drugs remain expensive despite more being approved. “All the competition isn’t really bringing down the price yet,” she said.
 
Another key trend is orphan drug development. Since these are very expensive drugs, costing $300,000 a year or more, they often go on to be blockbuster drugs, thus making them very lucrative for drug makers.
 
As a result, development of orphan drugs isn’t slowing. In the near-term pipeline, 35% of the drugs are orphan drugs. However, Tharaldson did note that the Government Accountability Office has recently announced it will look into potential abuses of the Orphan Drug Act.
 
Therapy Classes
Throughout the presentation, Tharaldson discussed 10 different therapy classes, including inflammatory conditions, where Enbrel and Humira are the market leaders and biosimilars will provide competition.
 
She recommended keeping an eye on the interleukin-23 inhibitors for treatment of psoriasis. There are 2 in the near-term pipeline, guzelkumab and tildrakizumab, both of which have been very promising.
 


 
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