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…
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…
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…
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…

