ABP - 501 an important additional approved therapeutic option for patients with chronic inflammatory conditions. Essay

Amgen's (NASDAQ AMGN) ABP 501 has been accepted by the U.S. Food and Drug Administration (FDA) for Biologics License Application (BLA). ABP 501 is a biosimilar candidate to Humiraregistered (adalimumab).
On the basis of clinical and pharmacokinetic data, BLA was submitted on November 25, 2015. Comprehensive clinical studies were done in Phase 3 to ascertain the efficacy and safety profile in the patients suffering from both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.
The primary end points were met in the Phase 3 trials comprehensively in efficacy, safety, and immunogenicity of ABP 501 with adalimumab. The drug maker has submitted the clinical data to the regulatory authority for BLA approval.
The drug maker received September 25, 2016, by the FDA for Biosimilar User Fee Act (BsUFA) target action date for ABP 501.
Amgen executive vice president of Research and Development Sean E. Harper, M.D. said "If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions."
He added "We look forward to potentially expanding our robust portfolio of approved products, and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide."
ABOUT ABP 501
ABP 501 belongs to a biosimilar category of adalimumab. It is an anti-TNF- monoclonal antibody, which is indicated in the treatment of several inflammatory diseases.
ABP 501 belongs to an anti-TNF- monoclonal antibody having the same amino acid sequence as adalimumab.
The Amgen's molecule consists of the same pharmaceutical dosage form as well as strength as adalimumab (US) and adalimumab (EU).
WHAT ARE BIOSIMILARS
A biosimilar is a biological product, which is highly similar to the biological product approved by FDA with no clinical differences regarding safety and effectiveness of the reference product. Minute inactive components of clinical variations are allowed in biosimilar products.
FDA has very strict rules in relation to the safety and efficacy of the drugs. Due to these strict measures, the health care professionals will be able to rely on the safety and effectiveness of the biosimilar or interchangeable product, just as they would the biologic product.
ABOUT AMGEN BIOSIMILARS
Amgen is utilizing its 35 years of experience in biotechnology to develop and manufacture human therapeutics for the treatment of patients suffering from various serious illnesses.
BIOSIMILARS OF HUMIRA
In December 2015, Baxalta Incorporated (NYSEBXLT) and Momenta Pharmaceuticals, Inc. (NasdaqMNTA) move a step ahead when the primary end points of M923 were met in a randomized, double-blind, three-arm, parallel group, single-dose study.
The main aim of the study is to evaluate the pharmacokinetics of M923 in comparison with HUMIRA and other reference products.
In July 2015, Merck ($MRK) and Samsung Bioepis announced that their biosimilar of Humira also cleared the last stage of the clinical trials.
The drug is in injection formulation known as SB5. In Phase II trials, It has met all the specific goals in comparison to Humira in patients suffering from rheumatoid arthritis showing an overall 20% improvement in symptoms after 24 weeks.
PREVALENCE OF RHEUMATOID ARTHRITIS