- Switching between adalimumab and adalimumab-fkjp in Phase 3
study in patients with chronic plaque psoriasis supports
interchangeability between adalimumab and adalimumab-fkjp
- Biosimilarity between Bmab 1200 and reference
biologic-Ustekinumab in pivotal Phase 3 trial in patients with
moderate to severe chronic plaque psoriasis
AMSTERDAM and BENGALURU,
India, Sept. 25, 2024 /PRNewswire/ -- Biocon
Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE
code: 532523, NSE: BIOCON), today announced new dermatology data
presented at the European Academy of Dermatology and Venereology
(EADV) 2024 Congress in Amsterdam.
The results from two separate pivotal Phase 3 clinical studies
supported interchangeability between adalimumab and adalimumab-fkjp
as well as underscoring biosimilarity of bUstekinumab.
Uwe Gudat, M.D., Chief Medical
Officer, Biocon Biologics said, "The extensive range of
new data being presented at EADV this year underscores Biocon
Biologics' commitment to a high-science portfolio of biosimilar
medicines that meet the clinical needs of physicians and patients
while providing important sustainability benefits to health
systems. These clinical studies support the interchangeability of
adalimumab-fkjp at low-concentration with high-concentration
adalimumab and ustekinumab biosimilarity without variation of
clinical outputs in patients with chronic plaque psoriasis."
Poster Title: Multiple switching between the biosimilar
adalimumab-fkjp low concentration and reference adalimumab high
concentration in patients with chronic plaque psoriasis: a phase 3,
double-blind, randomised, parallel-group study
Authors:
Sarika Deodhar, Subramanian Loganathan, Ramesh Ks, Gopi Ranganna, Shiyao
Liu, Matthew A. Hummel
Hummel, Stefan Daniluk, Anna
Hanczewska, Kamelia Vekovska, Maria Zegadlo-Mylik, Grazyna Pulka, Elena
Wolff-Holz
Abstract ID: 3809
Poster ID: P3241
Date/Time: 9:00am EDT, September 25, 2024
This study evaluated the pharmacokinetics (PK), efficacy,
safety, and immunogenicity in patients with moderate to severe
chronic Plaque Psoriasis (PPs) receiving adalimumab continuously
and those undergoing repeated switches between reference adalimumab
and adalimumab-fkjp. The primary objective was to evaluate
interchangeability of low-concentration adalimumab-fkjp (40
mg/0.8ml) and high-concentration adalimumab (40 mg/0.4ml) by
comparing adalimumab steady-state PK between switching and
non-switching arms.
The overall number and proportion of patients with Psoriasis
Area and Severity Index (PASI) responses and static Physicians
Global Assessment (sPGA) success were highly similar between the
two arms at week 28. Treatment-emergent Adverse Events were
comparable between switching [54 subjects (29.8%)] and
non-switching arms [66 subjects (34.2%)]. The overall number and
proportion of patients with PASI responses and sPGA success were
highly similar between the two arms at week 28.
This study confirmed that the subjects receiving adalimumab-fkjp
low concentration and adalimumab high concentration in alternate
fashion had highly similar time concentration curves compared to
continuous administration of high-concentration reference
adalimumab, and demonstrated PK equivalence between switching and
non-switching arms. The overall data supports interchangeability
between high-concentration adalimumab and low-concentration
adalimumab-fkjp.
This study was conducted to fulfill the U.S. Food and Drug
Administration (FDA) requirement for designation as an
"interchangeable" and has been submitted to the FDA.
Uwe Gudat, M.D., Chief Medical
Officer, Biocon Biologics said, "For physicians, an
important unmet need is understanding the comparative safety,
efficacy and exposure of an adalimumab biosimilar formulated at a
low concentration and high-concentration adalimumab at dose parity.
The data from the study shows clearly that in patients the same
safety, efficacy and exposure when used at dose parity can be
expected for both products. This in the context of multiple
switches between the reference product and the biosimilar as
required of an interchangeability study."
Poster Title: A Randomized, Double-blind, Parallel Group,
Multicenter, Phase 3 Study to Compare the Efficacy and Safety of
Bmab 1200 and Reference Biologic-Ustekinumab in Patients with
Moderate to Severe Chronic Plaque Psoriasis 28-week
Results
Authors: Jacek
Szepietowski, Adam Reich,
Steven Feldman, Grazyna Pulka, Lally Mekokishvili, Nino Junior
Tsiskarishvili, Inese Kolontaja-Zaube, Airi
Poder, Gursharan Singh,
Subramanian Loganathan, Elena Wolff-Holz, Sarika
Deodhar, Ashwani Marwah,
Sandeep Athalye
Abstract ID: 4382
Poster ID: P3266
Date/Time: 9:00am EDT, September 25, 2024
This pivotal Phase 3, randomized, double-blind, active
controlled, parallel-group, multicenter study compared the
efficacy, safety, immunogenicity, and pharmacokinetics (PK) of Bmab
1200 with the reference product ustekinumab in adult patients with
moderate to severe chronic plaque psoriasis (Pso).
A total of 384 patients were evaluated for 52 weeks and the
primary efficacy endpoint was percentage change from baseline
(%CFB) in PASI at Week 12. In the primary efficacy analysis at 28
weeks, Bmab 1200 and ustekinumab were equivalent and the data
support biosimilarity. The study established equivalent efficacy
and comparable safety of Bmab 1200 with ustekinumab in patients
with moderate to severe chronic plaque Pso.
Uwe Gudat, M.D., Chief Medical
Officer, Biocon Biologics said, "This pivotal trial of
bUstekinumab clearly met the safety and efficacy endpoints, thereby
fulfilling the expectations set for a biosimilar.
bUstekinumab offers tangible promise for all patients
qualifying for treatment with Ustekinumab."
About Biocon Biologics Limited:
Biocon Biologics Ltd. (BBL), a subsidiary of Biocon
Limited, is a unique, fully integrated, global biosimilars company
committed to transforming healthcare and transforming lives. It is
capitalizing on its 'lab to market' capabilities to serve millions
of patients across 120+ countries by enabling affordable access to
high quality biosimilars. The Company is leveraging cutting-edge
science, innovative tech platforms, global scale manufacturing
capabilities and world-class quality systems to lower costs of
biological therapeutics while improving healthcare outcomes.
Biocon Biologics has commercialized eight biosimilars in key
emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 12 biosimilar
assets under development across diabetology, oncology, immunology,
ophthalmology, and other non-communicable diseases. The Company has
many 'firsts' to its credit in the biosimilars industry. As part of
its environmental, social and governance (ESG) commitment, it is
advancing the health of patients, people, and the planet to achieve
key UN Sustainable Development Goals (SDGs).
Website www.bioconbiologics.com; Follow us on X
(formerly Twitter): @BioconBiologics and
LinkedIn: Biocon Biologics for company
updates.
Biocon Limited, publicly listed in 2004, (BSE code:
532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led
global biopharmaceuticals company committed to enhance affordable
access to complex therapies for chronic conditions like diabetes,
cancer and autoimmune. It has developed and commercialized novel
biologics, biosimilars, and complex small molecule APIs in
India and several key global
markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has
a pipeline of promising novel assets in immunotherapy under
development.
Website: www.biocon.com; Follow-us on
X (formerly
Twitter) @bioconlimited and LinkedIn:
Biocon for company updates.
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