Mylan biosimilar to stress test Amgen Neulasta franchise, analyst predicts

The importance of Mylan's copycat extends well beyond the bottom lines of the two drugmakers directly involved. Leerink analyst Geoffrey Porges called it "the latest battle" in the space that "will set the industry tone for biosimilar adoption in the near term."

Biosimilars are mainly struggling to clear legal and regulatory hurdles to reach the U.S. market, leaving Mylan's Fulphila (pegfilgrastim-jmdb) as an early test for the current disruptive power that these biologic copies can hold.

Out of the 12 biosimilars approved by the Food and Drug Administration, four are on the market (including Fulphila).

There are few riper opportunities for a biosimilar than Neulasta (pegfilgrastim), which had its final material U.S. patent expire in October 2015, opening the door to competition.

Neulasta grew into a top seller for Amgen after gaining the FDA's OK in 2002. It made up roughly 20% of the company's total sales in the last few years, netting $4.5 billion in 2017 and $2.26 billion through the first half of 2018.

Fulphila snagged FDA approval in June and promptly launched the following month. Now, Porges sees adoption of the copy as "relatively rapid in small physician practices and in 340B hospitals and institutions," which make up a little less than half of the Neulasta market.

Adoption in larger practices may lag in the short-term, he predicted, by the combination of preferable contracting and the availability of Amgen's OnPro device, a differentiator to the biologic that allows users to administer dosing at home the day after chemotherapy rather than going into a hospital or doctor's office. More than half of the Neulasta franchise includes the device, which was launched in 2015.

Leerink significantly changed their forecasts for both drugs after conducting interviews with oncology practice managers that led to their updated view. The bank now sees Mylan's copycat selling roughly $150 million in 2019 and $300 million in 2020, "significantly higher" than consensus, the report noted.

For Amgen, Leerink forecasts Neulasta will see sales cut in half by 2022 compared to its expectation for this year.

Copycat competition is gearing up to be problematic for Amgen. Not only could Fulphila and other inbound rivals disrupt the market for Neulasta, but a trial that recently started in New Jersey could clear the way for a biosimilar rival to Amgen's other multi-billion dollar drug, Enbrel (etanercept).

Yet, perhaps the most intriguing takeaways from the Neulasta-Fulphila battle will be the standard it could set in the space. It hasn't yet been proven that biosimilars can uproot biologics the way generics have with small molecule drugs in the U.S. market.

"More broadly," Porges wrote, "this launch is viewed by many investors as a litmus test of whether the biosimilars as whole will be a real threat to the established blockbuster biologic drugs."

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