This “Adalimumab- Biosimilar Insight, 2021,” report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Adalimumab Biosimilars: Marketed Drugs
Abrilada is an FDA-approved biosimilar version of adalimumab. Abrilada (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (Abrilada pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. Though approved, it is not yet marketed in the US like several other manufacturers of approved biosimilar versions of adalimumab, Pfizer has signed a licensing agreement with AbbVie; under the agreement, Samsung would be able to launch the drug in November 2023.
In December 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of Amsparity as a biosimilar to Humira (adalimumab) for the treatment of certain patients with RA, juvenile idiopathic arthritis, axial spondyloarthritis, PsA, psoriasis, hidradenitis suppurativa, Crohn’s disease, UC, uveitis, and pediatric plaque psoriasis.
Qletli: Bio-Thera Solutions
Qletli is an anti-TNF- ? monoclonal antibody. QLETLI binds specifically to soluble and membrane bound TNF-? and blocks its interaction with the p55 and p75 cell surface TNF receptors, effectively neutralizing TNF-? bioactivity. Bio-Thera Solutions has received approval from the country’s National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie’s Humira (adalimumab). It is the first Humira biosimilar approved in China. The drug secured approval for all eligible indications of Humira, including rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.
Adalimumab Biosimilars: Emerging Drugs
AVT02: Innovent Biologics
AVT02 is a monoclonal antibody (mAb) and a proposed biosimilar to Humira (adalimumab). It is being developed for the treatment plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, crohn’s disease, ulcerative colitis. AVT02 acts as immunosuppressants and tumour necrosis factor alpha inhibitors. In November 2020, Alvotech announced that its has filed a Biologics License Application (BLA) for AVT02 to the U.S. Food and Drug Administration (FDA), which has been accepted for review. The FDA is expected to decide on the filing in September 2021. Additionally, the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.
MYL-1401A is an anti-TNF monoclonal antibody. This tumor necrosis factor inhibitor is a proposed biosimilar of HUMIRA (adalimumab). MYL-1401A is a recombinant human IgG1 monoclonal antibody and is being evaluated as an injectable therapy for the treatment of rheumatoid arthritis and plaque psoriasis. Mylan has completed Phase III multicenter, double-blind, randomized, 2-arm, parallel-group, equivalence study, evaluating efficacy and safety similarity of MYL-1401A compared with Humira in subjects with moderate-to-severe chronic plaque psoriasis.
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Adalimumab Biosimilars?
- How many Adalimumab biosimilars are developed by each company?
- How many emerging biosimilars are in mid-stage, and late-stage?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Adalimumab biosimilars therapeutics?
- What are the clinical studies going on for Adalimumab biosimilars and their status?
- What are the key designations that have been granted to the emerging drugs?
- BioXpress Therapeutics
- ISU Abxis
- Zydus Cadila
- Tanvex Biopharma
- Gene Techno Science
- Genor Biopharma
- Meiji Seika Pharma
- Synermore Biologics
- Prestige BioPharma
- LG Chem
- Zhejiang Hisun Pharmaceuticals
- Boehringer Ingelheim
- Emcure Pharmaceuticals
- Fresenius Kabi
- Innovent Biologics
- Bio-Thera Solutions
- BX 2922
- GBS 005
- GB 232
- PBP 1502
- MYL 1401A
- HS 016
- BCD 057
- IDACIO (adalimumab)
For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/20e2ie