2018 Specialty Pharmacy Pipeline Drugs Could Make a Significant Budget Impact

October 18, 2017

During a session at AMCP Nexus 2017, Amiee Tharaldson, PharmD, senior clinical consultant of emerging therapeutics at Express Scripts, outline the upcoming specialty pharmacy pipeline drugs.

Dr Tharaldson explained that specialty drugs are specifically drugs designed to treat complex conditions, with administration often requiring dosing adjustments, intensive clinical monitoring, patient training, and specialized handling.

She outline some trends in the specialty drug market, and highlighted the fact that competition is increasing as approvals accelerated significantly in 2017 relative to 2016.

“We are seeing more medications approved in certain therapy classes, ranging from orphan conditions, cancer conditions, and even more common specialty therapy classes,” Dr Tharaldson said during her presentation. “This allows for more cost savings opportunities.”

Trends in Biosimilars

Dr Tharaldson also highlighted that increased competition amongst biosimilars will also create cost savings opportunities, with a potential for $46.2 billion in savings through 2021, due to patent expirations.

However, according to the presentation, some of the biosimilars already approved in 206 and 2017 will not impact the market for years due to patent protections. For example, Erelzi (etanerceptszzs)—a biosimilar to Amgen’s Enbrel for inflammatory conditions—could potentially not hit the market until 2029, despite being approved on August 30, 2016.

Dr Tharaldson did mention that there are two biosimilar products that will receive approval in the remainder of 2017. The first is trastuzumab (Mylan), a biosimilar to Genentech’s Herceptin for the treatment of breast cancer, which could be approved on December 3, 2017. The second is Grastofil (filgrastim; Apotex/Intas), a biosimilar to Amgen’s Neupogen for the treatment of Neutropenia, which is expected to be approved before 2018. Dr Tharaldson noted that these two drugs are not anticipated to be held up by patent issues, with Grastofil expected to launch in 2017 and trastuzumab in 2019.

She also highlighted the seven biosimilar products that are pending approval in 2018. Most notably, Retacrit (epoetin alfa; Pfizer) a biosimilar of Amgen’s Epogen for treatment of anemia, which is expected to launch in quarter 4 of 2018.

Dr Tharaldson outlined some of the key points and challenges associated the impact of biosimilars on the market.

“These are really acting like competing brands, the price discounts that we are seeing right now is about 15% to 30%, and there is a lot of legal hurdles that need to be overcome before these products can be launched, “ she said. Dr Tharaldson also pointed to the confusing new naming guidelines and the need for more interchangeability approvals as other barriers to market impact.

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