Biocon Biologics has received approval from the US Food and Drug Administration (FDA) for its diabetes treatment drug, insulin aspart marketed under the brand name Kirsty. Following the FDA nod, Biocon shares surged over 2%, reaching a 52-week high. This approval marks the first interchangeable insulin aspart product, NovoLog, gaining FDA clearance. The development is expected to positively impact Biocon's market position in diabetes care. Additionally, other pharmaceutical updates include Fresenius Kabi and Celltrion launching biosimilars for Prolia and Xgeva (denosumab), and Bio-Thera submitting an abbreviated Biologics License Application (aBLA) for a Simponi (golimumab) biosimilar named BAT2506. In related legal news, Amgen and Accord BioPharma have settled a denosumab Biologics Price Competition and Innovation Act (BPCIA) case.
Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506 https://t.co/ocaX6l0edg | by @venablellp
Applicant-admitted prior art may inform but can’t be basis for IPR challenges https://t.co/mddCWanBXV | by @mcdermottlaw
Valve turned: Prosecution history estoppel applies to closely related claims https://t.co/FVDYy68lw8 | by @mcdermottlaw