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 […]Read More
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More
Shots: The P-I AVT02-GL-101 study compares the PK, safety and tolerability of AVT02 to EU & US Humira and the PK of EU and US-Humira following a 40mg (SC) inj. in 392 healthy volunteers. The study has met its 1EP i.e. all PK endpoints are within the equivalence margins for all pairwise comparisons and demonstrated […]Read More
Shots: AbbVie has resolved the Humira litigation with BI, granting BI non-exclusive rights to BI for Humira’s IPR in the US BI will pay royalties for licensing HUMIRA patents and acknowledges the validity and enforceability of the licensed patents The initiation of the license will begin from Jul,1 2023 Click here to read full press […]Read More
Shots: The approval is based on Japanese P-III study results assessing Humira (adalimumab) in patients with moderate-to-severe HS, evaluating its efficacy and safety The study resulted in meeting its 1EPs as HiSCR @12 wks. in 13/15 patients, ADRs in 6/15 Humira (adalimumab) is an anti-TNF-α mAb approved in Japan for rheumatoid arthritis (RA), plaque psoriasis, […]Read More
Shots: The approval is based on SYCAMORE study assessing Humira (20mg, 40 mg, based on body wt.) + methotrexate vs methotrexate + PBO in 114 patients in a ratio (2:1) with active JIA-associated noninfectious anterior uveitis refractory to at least 12 weeks of methotrexate treatment aged > 2yrs. The SYCAMORE study resulted in meeting 1EPs, […]Read More
Shots: Pfizer to get worldwide IPR for Humira in the US and other countries and will pay royalties on sales to AbbVie Humira’s the US license right will begin from 20 Nov, 2023 and will be available in EU post EMA approval Humira (adalimumab) a mAb helps in blocking TNF protein, approved for 14 global […]Read More
Shots: Hulio’s EU Marketing Approval is followed after CHMP approval that demonstrated analytical, functional, clinical and immunogenicity data similar to AbbVie’s Humira In 2018, Kyowa and Mylan signed an agreement for exclusive commercialization right of Hulio in EU, and is expect to launch on or after 16 Oct, 2018 Adalimumab is an injectable, biologic medication […]Read More
Shots: This BLA is for the treatment of RA, PsA, AS, CD, UC, chronic psoriasis, HS, and JIA The clinical study included (PK/PD) and Ph III trials in ankylosing spondylitis showing its safety, efficacy and quality Bio-Thera is developing 7 biosimilars including BAT1406, with Avastin biosimilar currently being assessed in a global Ph III […]Read More
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