At the American Academy of Dermatology Annual Meeting, Sandoz announced that its proposed biosimilar adalimumab has met its primary endpoint for demonstrating efficacy in clinical trials.
The phase 3 study results found that the proposed biosimilar, GP2017, was in fact slightly more effective than the reference drug, AbbVie’s Humira. The primary endpoint was the proportion of participants with moderate to severe chronic plaque psoriasis who saw a 75% improvement in symptoms, as measured by the Psoriasis Area and Severity Index. After 16 weeks of treatment, 67% of those receiving the biosimilar achieved this benchmark, as did 65% of those on Humira.
At the end of the first 17-week study period, GP2017 had demonstrated favorable results for safety and immunogenicity, as the occurrence of adverse events and antibody reactions were similar to those observed in patients receiving the reference drug. Any adverse events were consistent with those listed in Humira’s safety profile.
Executives of Sandoz, a subsidiary of Novartis, heralded the trial data as an exciting step towards expanded access to treatment for patients with chronic plaque psoriasis.
"Currently, it is estimated that as few as five percent of eligible psoriasis patients get the biologics they need," said Mark Levick, MD, PhD, global head of development in biopharmaceuticals at Sandoz. "We are pleased the data reinforce the potential of our biosimilar adalimumab, if approved, to be another treatment option for moderate-to-severe chronic plaque psoriasis and other inflammatory diseases."
Sandoz plans to file its application for GP2017’s approval with both the European Medicines Agency and the FDA this year. The FDA filing was originally intended for the last quarter of 2016, but was pushed back due to concerns about the timing of regulatory inspections in conjunction with manufacturing facility upgrades, according to Novartis executives. Chief medical officer Vasant Narasimhan denied that the delay was due to any unfavorable clinical data for the proposed biosimilar.
GP2017 will be racing against another competitor, Coherus’s CHS-1420, as it travels through the development and approval pipeline. Less than a week ago, Coherus announced that its proposed adalimumab biosimilar achieved pharmacokinetic (PK) equivalence with the reference drug in clinical trials and had demonstrated comparable safety and tolerability profiles.
The president and CEO of Coherus, Danny Lanfear, said that the drug maker is confident it can “similarly complete future PK studies with modified formulations, anticipated to commence later in 2017.” He did not specify a timeline for submitting a regulatory application.
There is currently just 1 FDA-approved biosimilar for autoimmune drug adalimumab, Amgen’s Amjevita, but its launch has been held up by patent lawsuits from AbbVie. One analysis in 2015 reported that a yearlong course of AbbVie’s Humira cost an average of $27,665 after discounts, an increase of almost 50% from its cost 3 years prior.
Partnering for Biosimilar Security: India's Role in US Health Care Savings, Supply Chain Stability
May 9th 2024As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.