The FDA Oncology Advisory Committee unanimously voted to approve MYL/BIOS’ biosimilar Herceptin. The FDA is not required to mandatorily follow the committee’s recommendations, but given the data package, we believe an approval is highly likely, barring any facility issues. However, we see competitive dynamics continuing to deteriorate with Teva/Celltrion, Amgen, Pfizer and Merck/Samsung too likely to file their applications in coming months, making it a potentially five player market. SELL with a target price of Rs 230/share. The FDA Oncologic Drugs Advisory Committee (AdCom) unanimously recommended the approval of MYL/BIOS’s Herceptin biosimilar application. The unanimous vote is not surprising given strong PK and clinical efficacy/safety data presented at May’16 ASCO and particularly, in the light of the briefing documents which highlighted an overwhelmingly strong analytical and clinical data package.
Following the AdCom vote, we await FDA’s decision on the product, with a BsUFA date of Sept’17. The FDA is not required to follow the AdCom recommendations, but we believe an approval is a highly likely, barring any issues at the fill and finish facility, which had received eight observations in an Apr’17 pre-approval inspection and had recently been given a non compliance status by the French drug regulator.
MYL’s settlement with Roche means that it will only be able to launch its biosimilar Herceptin in the US in H2CY18. In the meantime, several competitors are lining up potential filings / launches, with Teva / Celltrion likely to file immediately, following a strong clinical data package that was presented at ASCO 2017, Amgen, on track for an aBLA filing for ABP215 in Q3CY17, Pfizer on track for its H2CY17 US filing for PF-05280014, and Merck / Samsung too showcasing a strong clinical data at ASCO 2017, with a filing anticipated in H2CY17. We expect most, if not all these players to launch by CY2019, making biosimilar Herceptin a five player market, and given the strong oncology presence of Amgen, Pfizer, Merck and even Teva, we believe Mylan will face tough competition in gaining share, with pricing too likely to come under pressure.