EpiPen RICO Ruling Opens Door for Private AKS Enforcement
Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows...more
Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets....more
In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines: (1) Fujifilm...more
Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more
On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported, Biocon had earlier requested...more
Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of...more
As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency...more
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European...more
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European...more