Most biopharmaceutical industry experts now consider biosimilars to be mainstream products, indicating that the field has progressed immensely over the past 10 years. Nevertheless, when comparing approvals and commercial offerings across the globe between 2013 and 2020, it becomes clear that some regions welcome these therapies more than others do. Western European biosimilars markets continue to be kind to these drugs’ production, distribution, and coverage; and companies headquartered in Asia and the Pacific Rim increasingly are getting involved in biosimilars…
Friday, June 12, 2020 Daily Archives
Spark on changing cell and gene regulatory expectations
Regulators are increasingly looking to industry to turn the science of cell and gene therapies into reproducible platform technologies, says Spark Therapeutics’ Diane Blumenthal. The advancements in the cell and gene therapy space were applauded throughout Xconomy’s virtual Xcelerating Philadelphia event last night as industry experts spoke about the increasing number of such therapies moving through the clinic and the hurdles that industry is rapidly knocking over. But challenges continue to exist, and in a panel focused on regulatory pathways,…
Gilead’s Kite receives EMA OK for Amsterdam CAR-T plant
The $150 million facility in The Netherlands is now fully operational and will produce CAR-T therapy Yescarta for up to 4,000 patients per year, says Kite. In 2018, Gilead Sciences, fresh from its $11.9 billion acquisition of Kite Pharma, announced plans to open a European facility to manufacture chimeric antigen receptor (CAR) T-cell therapies. Today the firm has announced the 204,514 square-foot site – the largest in Kite’s network – has received approval from the European Medicine Agency (EMA) for…