Shots: The purpose of the switching study (AVT02-GL-302) is to support the approval of AVT02 in the US as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms of Humira. The results of the study are expected in late 2021 In May’21, Alvotech sued to end AbbVie’s wrongful monopoly on Humira and bring […]Read More
Shots: Alvotech has filed a federal lawsuit to end the monopoly on AbbVie’s Humira for taking several improper steps to inflate its patent portfolio includes multiple patents on the same invention and obtain patents through inequitable conduct Alvotech develops AVT02 as a biosimilar of Humira for chronic pain with equal in strength to Humira’s latest […]Read More
Shots: Health Canada has authorized Hyrimoz on Nov 4, 2020 for marketing in Canada. Hyrimoz has been approved for use in all same indications as reference Humira, including rheumatology, gastroenterology and dermatology A patient support program will be available to patients treated with Hyrimoz providing guidance with reimbursement navigation, financial assistance, administrative support & education […]Read More
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 […]Read More
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
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