Skip to content Skip to footer
UCB

The US FDA Approves UCB’s Zilbrysq Autoinjector for Self-Administration in AChR+ gMG

Shots: The US FDA has approved UCB’s Zilbrysq (zilucoplan) autoinjector for once-daily self-administration in adults with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, adding to the existing prefilled syringe option Supportive data incl. P-I (DV0012) bioequivalence vs PFS in healthy volunteers (n=14) and P-IIIb (DV0013) in adults with gMG (n=31), where complete dose…

Read more

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…

Read more

Insights+ Key Biosimilars Events of October 2023

Insights+ Key Biosimilars Events of October 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  During the month of October, Boehringer launched adalimumab injection (biosimilar, Humira) for multiple…

Read more

VIEWPOINTS_Stephen Pagnotta_2023

Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo

Shots: Stephen gave a brief introduction about Cyltezo (an FDA-approved interchangeable Humira biosimilar) and spoke about the features of the Cyltezo Pen (a new autoinjector) approved by the US FDA He also gave a comparative view of the Cyltezo Pen vs. the conventional Cyltezo PFS. He also talked about how BI is informing and educating…

Read more