We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the…
Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the…
Mabion We previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP). In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…
The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar. According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.” …
On Feb. 13, 2020, the European Medicines Agency (EMA) granted market authorization for Amsparity, Pfizer’s adalimumab biosimilar. Amsparity is approved for use in treating the same set of conditions as Humira in Europe. In 2018, Pfizer announced that it had reached a license agreement with AbbVie that allowed Pfizer to…
The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech. According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…
Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710. According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…
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 European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan…
Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.” The Department is now asking the public for its views regarding the…
The European Medicines Agency (EMA) and the European Commission have jointly released an informational guide on biosimilars for healthcare providers. The guide aims to inform healthcare providers about the benefits of biosimilars to their practices and patients. Professor Guido Rasi, Executive Director of the EMA, states the following in his Foreword:…