While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

Sandoz says it will use a third-party manufacturer as its proposed Humira biosimilar receives recommendation in Europe. Meanwhile, the US FDA has rejected Amgen’s proposed Herceptin biosimilar. Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Halimatoz, Hefiya and Hyrimoz – all versions of AbbVie’s best-selling Mab Humira (adalimumab) submitted by Novartis subsidiary Sandoz. “To ensure the majority of eligible patients gain access to our biosimilar medicines as soon as possible,…

With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year. In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701. The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information. Earlier this month, Coherus announced it resubmitted its…