Biosimilar Confidence: Patient Perspectives on a New Medication Class

Imagine you’ve been living with rheumatoid arthritis for more than ten years. Likely, it took several years to get a definitive diagnosis, with crucial time lost before landing at the doorstep of the expert (the rheumatologist). And then a bevy of sequential prescriptions ranging from steroids to methotrexate to biologics to find the medication, or combination of medications, that works well and minimizes flares. There’s a rollercoaster of emotions – fear, hope, reluctance, relief, which all vary person-to-person. But one thing is unanimous no matter who the patient is:  she or he must proactively be their own advocate in the care and management of their disease.

Speaking on behalf of CreakyJoints, the organization I founded with social entrepreneur Louis Tharp in my dorm room 17 years ago that now serves more than 100,000 arthritis patients and their families worldwide who are seeking education, support, advocacy and patient-centered research, we’ve had a front row seat to witness the miracle of treatments that have developed over the years. We remember gold injections or Indocin pills, but we also remember the game changers of biologics, and what they did for us. Which is why today, we’re optimistic and excited about biosimilars entering the marketplace as the latest therapeutic option. Simply by being similar, though not exactly identical to the original medication, they represent an additional treatment option, which is critical for us. We like our tool-box filled with tools that we can use to combat our diseases.  [[{"type":"media","view_mode":"media_crop","fid":"50166","attributes":{"alt":"Seth Ginsberg","class":"media-image media-image-right","id":"media_crop_2422993359564","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"6105","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"Seth Ginsberg","typeof":"foaf:Image"}}]]

But like any new medication class, there are unknown variables which will impact the uptake of biosimilars by prescribing physicians and patients alike. Confidence in both the efficacy and the safety of these medications is first dependent on the FDA and its independent Arthritis Advisory Committee evaluating Biologic License Applications (BLA) carefully and thoroughly. On July 12, the Arthritis Advisory Committee convened to discuss BLA 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA (adalimumab), submitted by Amgen, Inc. Immediately following on July 13, the committee met to evaluate BLA 761042, for GP2015, a proposed biosimilar to Amgen Inc.’s ENBREL (etanercept) submitted by Sandoz, Inc.  The potential FDA approval of either of these medications meant to mimic blockbuster drugs is notable because the BLAs propose expansive indications that will reach millions of patients living with a wide range of chronic disease including rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, severely active ulcerative colitis, active arthritis, psoriatic arthritis and plaque psoriasis.

For ABP 501, we believe the Amgen has shown exemplary effort to increase patient and physician confidence by providing clinical studies that prove safety and efficacy for two indications, rheumatoid arthritis and plaque psoriasis, surpassing the FDA requirement of just one. Further, the applicant created assays with extraordinarily high level of sensitivity to gauge the biosimilarity of their molecule to the reference product. Therefore, we support approval of these medications.

However, our excitement and confidence in biosimilars as a new medication class is tempered by the realization that many questions remain unanswered. For example, in terms of support, will manufacturers provide support services to the patient community? Can we call a nurse hotline if we need to? Is there a starter kit to show us how to use and store the medicine? We hope that biosimilars don’t become “second class citizens” in terms of the patient experience and the companies will offer similar, if not identical, levels of support and transparent reporting on its production, safety and supply chain.

​And then there’s the cost issue. Will patients see any real cost savings promised by less expensive biosimilars? Already, we have to go through great lengths to access medications as step therapy practices aim to reduce costs for payers, not patients. Given that the manufacturing of biosimilars will cost less than biologics, will payers, eager to accrue savings for themselves, attempt to switch a patient from a drug that works to one they don’t know – just to appease shareholder demand for higher profits?

It will be very tempting, almost irresistible, for payers to engage in non-medical switching, particularly because, as pointed out by the RAND Corporation, if every patient transitioned to a biosimilar then spending on biologics will fall by between 10 and 50 percent. Hence, there is a significant cost saving to the health system. But the same report points out there is no solid evidence regarding how those cost savings would be passed down to the patient populations.

Although it is a controversial topic among the patient community, we support FDA’s position to allow extrapolation of indications as it is needed in order to reduce cost and increase reach. However, we respectfully oppose extrapolation when the mechanism of action for the extrapolated indication is not clearly understood or the drug is considered scientifically or therapeutically outdated. We don’t want more mediocrity. We want more of the best in class.

Science is only part of biosimilar success. Ultimately, use of and satisfaction with biosimilars is where success will be measured. CreakyJoints is optimistic about this medication class and we look forward to taking biosimilars. Through ArthritisPower, our PCORI-funded Patient Powered Research Network registry, we will embrace and ultimately track patient-reported outcomes resulting from biosimilars. That will be the best measure of their success.

Seth Ginsberg is president and co-founder of the Global Healthy Living Foundation and CreakyJoints.