FDA NewsPerspective

FDA advisory committee unanimously recommends approval of biosimilar to Enbrel

The FDA Arthritis Advisory Committee voted 20-0 in favor of recommending the approval of GP2015, Sandoz’s proposed biosimilar to Amgen’s Enbrel.

Sandoz is seeking licensure to use the biosimilar to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If approved, Sandoz noted GP2015 will help expand treatment options available to patients, health care providers and payers.

“We are encouraged by today’s favorable advisory committee recommendation for our proposed biosimilar etanercept,” Mark McCamish, MD, PhD, head of global biopharmaceutical development at Sandoz, said in a company press release. “As a global market leader in biosimilars, we are pleased to move one step closer toward our goal of expanding patient access with our proposed biosimilar etanercept, and look forward to continuing to work with the FDA as they complete their review of our application.”

According to the release, analytical, preclinical and clinical studies, including four comparative pharmacokinetic studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis, demonstrated biosimilarity between the company’s biosimilar etanercept and etanercept.

Despite positive outcomes, panel members raised a few concerns about labeling and post-marketing studies. Andreas M. Reimold, MD, chief of rheumatology at the Dallas VA Medical Center, noted the label for the biosimilar should “clearly state that this is a biosimilar, not an interchangeable drug.”

David J. Margolis, MD, PhD, professor of dermatology and epidemiology at the University of Pennsylvania School of Medicine, stressed the importance of post-marketing studies to “demonstrate that extrapolation was correct and it is in the overall safety of the products long term.”

“I think non-medical switching is a major concern of clinicians and policy makers that we have to have some greater clarification from the agency. If there is some statement to be made, make it soon,” David Solomon, MD, MPH, acting chair on the advisory board and chief of the Section of Clinical Sciences, Division of Rheumatology, Division of Pharmacoepidemiology at Brigham and Women’s Hospital, said. “I think the post-marketing surveillance issues are going to be critical to understand the validity of the extrapolation.”

Mara L. Becker, MD, MSCE, associate professor of pediatrics at the University of Missouri-Kansas City, also noted that with 25 mg/0.5 mL being the lowest strength of GP2015, which corresponds to the approved strengths of Enbrel, some pediatric patients may still be limited with treatment options.

“The reality is that, [with] the data present[ed] today, it was convincing that this application is similar enough to etanercept that I would feel comfortable using it in the children that I treat,” Becker said. “However, at this time, I cannot because there are plenty of kids less than 20 kilos that we may need to use this on. So, with an indication for JIA down to the age of 2 [years], you are limiting some patient accessibility with the current formulations.” – by Casey Tingle

 

Reference:

www.novartis.com

 

The FDA Arthritis Advisory Committee voted 20-0 in favor of recommending the approval of GP2015, Sandoz’s proposed biosimilar to Amgen’s Enbrel.

Sandoz is seeking licensure to use the biosimilar to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (JIA) in patients aged 2 years or older, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If approved, Sandoz noted GP2015 will help expand treatment options available to patients, health care providers and payers.

“We are encouraged by today’s favorable advisory committee recommendation for our proposed biosimilar etanercept,” Mark McCamish, MD, PhD, head of global biopharmaceutical development at Sandoz, said in a company press release. “As a global market leader in biosimilars, we are pleased to move one step closer toward our goal of expanding patient access with our proposed biosimilar etanercept, and look forward to continuing to work with the FDA as they complete their review of our application.”

According to the release, analytical, preclinical and clinical studies, including four comparative pharmacokinetic studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis, demonstrated biosimilarity between the company’s biosimilar etanercept and etanercept.

Despite positive outcomes, panel members raised a few concerns about labeling and post-marketing studies. Andreas M. Reimold, MD, chief of rheumatology at the Dallas VA Medical Center, noted the label for the biosimilar should “clearly state that this is a biosimilar, not an interchangeable drug.”

David J. Margolis, MD, PhD, professor of dermatology and epidemiology at the University of Pennsylvania School of Medicine, stressed the importance of post-marketing studies to “demonstrate that extrapolation was correct and it is in the overall safety of the products long term.”

“I think non-medical switching is a major concern of clinicians and policy makers that we have to have some greater clarification from the agency. If there is some statement to be made, make it soon,” David Solomon, MD, MPH, acting chair on the advisory board and chief of the Section of Clinical Sciences, Division of Rheumatology, Division of Pharmacoepidemiology at Brigham and Women’s Hospital, said. “I think the post-marketing surveillance issues are going to be critical to understand the validity of the extrapolation.”

Mara L. Becker, MD, MSCE, associate professor of pediatrics at the University of Missouri-Kansas City, also noted that with 25 mg/0.5 mL being the lowest strength of GP2015, which corresponds to the approved strengths of Enbrel, some pediatric patients may still be limited with treatment options.

“The reality is that, [with] the data present[ed] today, it was convincing that this application is similar enough to etanercept that I would feel comfortable using it in the children that I treat,” Becker said. “However, at this time, I cannot because there are plenty of kids less than 20 kilos that we may need to use this on. So, with an indication for JIA down to the age of 2 [years], you are limiting some patient accessibility with the current formulations.” – by Casey Tingle

 

Reference:

www.novartis.com

 

    Perspective
    Seth Ginsberg

    Seth Ginsberg

    The overall aim of biosimilar is to help contribute toward the reduction of cost for patients. Among the important attributes for the arthritis community specifically is biosimilar confidence. That is confidence on the patient’s part, as well as the prescriber’s part, that the medication is going to be safe and effective as the originator product. Without biosimilar confidence, there could be massive tension for disruption and negativity.

    When we look at what makes one confident in a biosimilar, we look first at the manufacturers’ safety track records. We evaluate if they already make safe drugs as well as the sustainability of their supply chains. It is important because when we look at new manufacturers on the market, which is not necessarily applicable to the manufacturers in this week’s hearings, we hope they can produce as much as is needed for patients. Using biosimilars produced by similar manufacturer whose supply chain is inadequate will mean one that one will need to go to another biosimilar from another manufacturer. This unnecessary switch could potentially complicate things. We also look at support services, meaning all of the components associated with the drug itself. Patients and prescribers need to be confident in the biosimilar.

    There is also a need for the cost savings to trickle down to patients. Care and the pharmacy benefit managers are likely to take the majority of the cost savings. However, from a patient’s perspective, a cost-saving needs to be realized so there is something for the patient. These are some of the attributes of what we call “Operation Biosimilar Confidence,” which is about fulfilling confidence among patients and physicians.

    Another issue is extrapolation. Indications should be extrapolated only for the best in class, and not for outdated or inferior mechanisms.

    It will be exciting to take the intricacies and complexities of the FDA approval process, advisors committee process, scientific review process and public stakeholder engagement process, and explain it in lay terms for patients and families. There is a need to educate patients and the public about what is going on and the rheumatology community can contribute to the process. Our job is to bridge the important regulatory affairs of the FDA with the day-to-day human lives the regulations impact.

    • Seth Ginsberg
    • President and Co-founder CreakyJoints and the Global Healthy Living Foundation Upper Nyack, N.Y.

    Disclosures: Ginsberg reports CreakyJoints and the Global Healthy Living Foundation receives funding in the form of grants and sponsorships from manufacturers, Patient-Centered Outcomes Research Institute and other private foundations.

    See more from Biosimilars in the United States: Current Status and Future Implications