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AMCP 2016

What Is Coming in Specialty Pharmacy? A Look at the Near-Term Drug Pipeline

Laura Joszt
AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016 kicked off by delving into the near-term specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts.
AMCP Managed Care & Specialty Pharmacy Annual Meeting 2016 kicked off by delving into the near-term specialty pharmaceutical pipeline with Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapies at Express Scripts.
 
She kicked off the session with a discussion on competition, which will increase in the coming years. There are 40 patent expirations through 2020, which represents a $16 billion opportunity for generics.
 
In addition, there is a lot of opportunity for biosimilars, with 56 patent expirations through 2020, which represents a $43.8 billion opportunity. However, she noted that just because there is a patent expiration date does not mean a biosimilar will be launched at that time.
 
For example, Inflectra was approved April 5, 2016, with a possible launch date 180 days after approval, which would be October 2, 2016. While Pfizer and Celltrion are planning on launching in 2016, Dr Tharaldson explained that litigation could delay the launch.
 
There are an additional 6 biosimilars awaiting approval in 2016: Sandoz’s etanercept (biosimilar to Amgen’s Enbrel); Sandoz’s pegfilgrastim (biosimilar to Amgen’s Neulasta); Amgen’s adalimumab (biosimilar to AbbVie’s Humira); Apotex’s grastofil (biosimilar to Amgen’s Neupogen); Apotex’s pegfilgrastim (biosimilar to Amgen’s Neulasta); and Pfizer’s retacrit (biosimilar to Amgen’s Epogen and Janssen’s Procrit).
 
“But with all of these, there is a lot of uncertainty,” Dr Tharaldson said, adding that there will “be a lot of legal hurdles to get these products to market.”
 
When biosimilars first come to market, they will initially act like competing brands with a price discount of 15% to 30%.
 
Dr Tharaldson also took the time to discuss orphan and cancer medications, which is a key specialty pharmaceutical trend. Although orphan drugs treat small populations, they are very expensive and 30% of orphan medications are blockbusters with annual sales greater than $1 million.
 
“So it’s lucrative for manufacturers to develop orphan medications; it’s also great for patients that those conditions,” she said.
 
More than one-fourth of specialty drugs in the pipeline are for orphan indications. Another 25% of specialty drugs in development are cancer drugs.
 


 
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