Mylan NV has received U.S. Food and Drug Administration approval to market its biosimilar of Amgen Inc.’s drug Neulasta.
Canonsburg, Penn.-based Mylan announced the development on Monday. The medication – named Fulphilia – was co-developed with Biocon Ltd. in India. It is the only Neulasta biosimilar so far approved by the FDA; others from Novartis AG and Coherus BioSciences Inc. have been rejected.
In a statement to the Business Journal, the Thousand Oaks pharmaceutical company reiterated that each manufacturer’s product is distinct.
“Though (Fulphilia) is highly similar to Neulasta, the U.S. Food and Drug Administration has not approved its use as interchangeable with Neulasta,” Amgen said. The company has a proprietary Neulasta delivery system, Onpro, which injects the medication through a pre-filled on-body patch.
Neulasta is approved for preventing infections in patients undergoing chemotherapy for non-myeloid cancers, or those that don’t affect the bone marrow. Worldwide sales of the drug fell 5 percent year over year to $1.15 billion in the first quarter of 2018, according to Amgen filings, marking the fourth straight period of declines. Full-year sales of the drug were $4.2 billion for the 12 months ended March 31, according to health information technologies and research firm IQVIA.
Competition from biosimilars approved in Europe and less demand for the drug overall have contributed to the declines, reports have suggested. The development of unique delivery platforms like Onpro, which was approved in Europe earlier this year, has been posited as one way biotechs with name-brand drugs are staving off pressure from companies that are manufacturing biosimilars of their products.
Shares of Amgen (AMGN) closed Monday up $1.87, or about 1 percent, to $185.44 a share.