On August 31, 2022, Biocon Biologics released a statement regarding three recent on-site FDA inspections of seven manufacturing facilities spanning two sites in Bengaluru, India and one site in Johor, Malaysia. The inspections took place between August 11 and August 30, 2022. The inspections were triggered by three preapproval inspections…
On December 1, 2021 the government of British Columbia announced that it is further expanding its biosimilar initiative. The statement reported that as of November 30, 2021 an estimated 30,000 patients on the rapid-acting insulin lispro (Humalog) and insulin aspart (NovoRapid) would have six months to transition to the respective…
Last week, the EMA authorized Insulin aspart Sanofi’s biosimilar product. The EMA notes on its website that Insulin aspart Sanofi is “highly similar to another biological medicine [NovoRapid] that is already authorized in the EU.” Insulin aspart Sanofi contains the active substance insulin aspart, a rapid-acting insulin, and received marketing…