Amgen (AMGN) Buy Retained at RBC as Neulasta Biosimilar May Not Come Until Next Year at Earliest

RBC Capital maintained an Outperform Amgen (NASDAQ: AMGN) price target of $190. Analyst Michael J. Yee pointed out that Amgen formally sued over a potential Neulasta biosimilar, with the case scheduled for mid-2016. In his view, the biosimilar may not come this year.

"We've said we think a surprise upside vs consensus for AMGN would be if Neulasta biosimilar doesn't come this year or gets delayed due to: 1) Apotex biosimilar does not get approved for some reason, or 2) litigation ties up the drug well into 2016," said Yee.

"On point #2, it is now public that AMGN has sued Apotex (and is seeking an injunction) claiming infringement of two patents ('138 and '784) and violation of the BPCIA act failing to give 180-day "effective notice" of commercial marketing given the drug hasn't been approved so they cannot give appropriate timeline guidance (and supported by Federal Circuit ruling in Neupogen biosimilar case where that too was delayed to Sep launch failing the 180 day notice after biosimilar is licensed). The case isn't scheduled to be heard until July 2016," continued the analyst.

Yee added, "So this could be positive for AMGN based on adding possible higher bar to any biosimilar launch ie even assuming an approval, 1) Apotex might not launch at risk and until past July 2016 after any court rulings are decided, 2) AMGN might win in litigation (will come down to enforcing patents in part related to process and manufacturing of biologics), 3) adds time for AMGN to convert customers to on-body Neulasta device."

For an analyst ratings summary and ratings history on Amgen click here. For more ratings news on Amgen click here.

Shares of Amgen closed at $168.56 yesterday.

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