Five Biologic Blockbusters Opened Up To EU Biosimilar Competition In 2017
A total of 16 biosimilar products were approved in 2017, including the first competitors to five biologic blockbusters. Coincidentally, 16 other biosimilars are also under evaluation by the European Medicines Agency’s main scientific committee, the CHMP, including six versions of Amgen’s Neulasta (pegfilgrastim) and five more biosimilars of AbbVie’s Humira.
You may also be interested in...
Twenty-eight new products containing a total of 29 new active substances were authorized for marketing in the EU in 2017, very much line with the 2016 tally. As in that year, oncology dominated the 2017 approvals, which also included new drugs for rheumatoid arthritis, skin & blood disorders, and hepatitis C.
A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a potential multiple myeloma therapy derived from sea squirts.
At its November meeting, the CHMP finally OKd Roche's Ocrevus for multiple sclerosis and gave the green light to new drugs for eosinophilic esophagitis, CMV, hemophilia A, and vaginal atrophy, as well as Amgen’s Mvasi, the first EU biosimilar version of Roche’s Avastin. The committee upheld two earlier negative opinions, and two products were withdrawn from the assessment process.