Mylan’s Neulasta biosimilar gets positive CHMP opinion
Mylan’s (MYL) Fulphila (pegfilgrastim), a biosimilar of Amgen’s (AMGN) Neulasta, received a positive CHMP (Committee for Medicinal Products for Human Use) opinion on September 21. This is expected to positively impact the review of the drug’s MAA (Marketing Authorization Application) by the EC (European Commission). The approval for Fulphila in Europe is expected by November. The drug is used to help reduce the risk of infection during cancer treatments.
Two other Neulasta biosimilars—Cinfa Biotech’s Pelmeg and Sandoz’s Ziextenzo—also received a positive CHMP opinion on September 21. Sandoz is a division of Novartis (NVS). On September 25, Coherus BioSciences’ (CHRS) Udenyca received EC approval and became one of the first Neulasta biosimilars to be approved in Europe. CHRS stock was up ~6.0% on the news. The drug is under review in the United States and is expected to receive approval in November.
Neulasta biosimilar approved in the US
Mylan (MYL) received FDA approval for Fulphila in June, and the drug was launched in the United States in July. MYL stock rose ~5.0% during after-hours trading on June 4. Mylan’s Fulphila is the first Neulasta biosimilar approved in the United States.
The drug is expected to generate significant sales during the second half of the year and beyond. Mylan has submitted regulatory applications in other countries, including Canada, Australia, and New Zealand.
In the next article, we’ll look at Wall Street’s ratings and estimates for Mylan’s Fulphila.
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