(adalimumab)

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases

Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, …

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases Read More »

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021

Shots: The P-III CT-P17 3.1 trial involves assessing Yuflyma (adalimumab, 40mg, high-concentration formulation, low-volume and citrate-free, q2w, up to 24 wks.) vs reference adalimumab in a ratio (1:1) in 648 patients with active RA The one year data demonstrated comparable efficacy of Yuflyma to reference adalimumab in terms of ACR20/50/70 response rates in patients receiving …

Celltrion Presents One Year Results of Yuflyma (biosimilar, adalimumab) in P-III CT-P17 3.1 Trial for Rheumatoid Arthritis at EULAR 2021 Read More »

Amgen Launches Amgevita (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases in Canada

Shots: The company reports the availability of Amgevita, referencing Humira to treat 11 chronic inflammatory conditions in Canada Amgevita is available as a prefilled syringe and a prefilled pen (SureClick autoinjector) with a broad range of pack sizes to support dosing for each indication and available in a citrate-free formulation. Amgevita is reimbursed on the …

Amgen Launches Amgevita (biosimilar, adalimumab) for the Treatment of Multiple Chronic Inflammatory Diseases in Canada Read More »

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada

Shots: Samsung Bioepis in collaboration with Merck broadens its global reach by launching Hadlima in Australia for multiple autoimmune diseases With the launch in Australia, Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada, and Australia Hadlima is Samsung Bioepis’ third anti-TNF biosimilar launched in Australia, following the launch of Brenzys (etanercept) and …

Samsung Bioepis Expand its Footprints with the Launch of Hadlima (biosimilar, adalimumab) in Australia and Canada Read More »

Coherus Reports the US FDA’s Acceptance of BLA for CHS-1420 (biosimilar, adalimumab)

Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch the CHS-1420 in the US on or after Jul 01, 2023 as per the terms of an agreement with AbbVie Coherus collaborated with Junshi in Feb’2021 to in-license toripalimab in …

Coherus Reports the US FDA’s Acceptance of BLA for CHS-1420 (biosimilar, adalimumab) Read More »

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 …

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

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 …

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