Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more
The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars....more
Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU: On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more
Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also...more
Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for...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