AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Shots:

  • The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who were diagnosed with PG but were not sufficiently effective with local treatment, or who were judged to be unsuitable for local treatment
  • Result: The proportion of patients achieving at 100 (targeted PG ulcer healed) of the target PGAR @26wks. of administration (54.5%)
  • The indication marks Humira’s 12th indication in Japan and making it the world’s first drug indicated for the treatment of PG. Humira has received MHLW’s ODD for the treatment of PG in 2019

Click here ­to­ read full press release/ article | Ref: Eisai | Image: Owned

The post AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum first appeared on PharmaShots.

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Shots:

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: pharmaceutical daily

The post Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab) first appeared on PharmaShots.