Biogen and Samsung Bioepis Co., Ltd. have three exciting new anti-tumor necrosis factor (anti-TNF) biosimilars under development to treat patients with rheumatoid arthritis. Representatives from the companies will present data at the European League Against Rheumatism Annual Congress (EULAR 2015), which is being held this year in Rome. Findings indicate that these three therapies are promising candidates for rheumatoid arthritis.
“Biogen is committed to bringing biosimilars of advanced biologics to the healthcare market,” said John Cox, Executive Vice President of Pharmaceutical Operations and Technology at Biogen, in a news release. “With our leading manufacturing capabilities and deep scientific expertise, we believe we are well positioned to bring the three most commonly used anti-TNF therapies to physicians, payers, and ultimately the patients who need them most.”
Two biosimilars, SB4 (etanercept) and SB2 (infliximab) are clinically comparable to the brand name treatments Enbrel® and Remicade®. Data at EULAR 2015 for these therapies are in reference to head-to-head Phase 3 studies evaluating the similarities between biosimilars and their respective reference products. The third, SB5 (Adaliimumab) is a biosimilar for Humira®. A presentation at EULAR 2015 will discuss Phase 1 pharmacokinetic data comparing SB5 to Humira.
SB4 will be discussed in two poster presentations: “A Phase III Randomised, Double-Blind Clinical Study Comparing SB4, An Etanercept Biosimilar, With Etanercept Reference Product (Enbrel®) in Patients With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week Results)” and ” A Phase I Pharmacokinetic Study Comparing SB4, An Etanercept Biosimilar, and Etanercept Reference Product (Enbrel®) in Healthy Male Subjects.” The main highlight of the study identified an American College of Rheumatology 20% improvement (ACR20) in 73.8% of SB4-treated patients and 71.7% of etanercept-treated patients after 24 weeks.
Two similar poster presentations will be given for SB2 at EULAR 2015. “We are excited by the positive results from these three equivalence studies, including the Phase III data for SB4 and SB2,” stated Christopher Hansung Ko, CEO of Samsung Bioepis. “The results presented at EULAR are part of the robust data packages intended to support the global regulatory filings for each.”
Finally, “A Phase I Pharmacokinetic Study Comparing SB5, an Adalimumab Biosimilar, and Adalimumab Reference Product (Humira®) in Healthy Subjects,” is a poster presentation for SB5. This study identified a similar pharmacokinetic profile between the two treatments. Patients had similar safety profiles on the treatments as well.
Developing biosimilars is a major advantage for the companies. First, producing complex biological proteins that have similar effects despite different origins is a large scientific feat. Second, by establishing biosimilars, Biogen will continue to benefit from its commercial endeavors despite the inevitable expiration of its original treatment patents. Of course, rheumatoid arthritis patients will continue to benefit as well, as they will continue to have access to efficacious products.
