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A multidisciplinary task force comprising 25 experts from ten countries (eight European countries, the USA, and Japan) has concluded that sufficient scientific evidence exists to support the switch from originators to biosimilars to treat rheumatic diseases. The task force included experts in rheumatology, dermatology, and gastroenterology, as well as pharmacologists, patients, and a regulator. Their goal was to develop an evidence-based statement on the use of biosimilars in rheumatic diseases by assessing the available literature. Analysis of 29 publications led to five overarching principles and eight consensus recommendations covering issues such as clinical trials, immunogenicity, extrapolation of indications, switching between originators and biosimilars, switching from one biosimilar to another, and cost implications. The group concluded that biosimilars are unlikely to clinically differ from originators but encouraged healthcare providers to gather pharmacovigilance data in registries about the outcome of switches. Their report, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases,” has appeared in Annals of the Rheumatic Diseases.
The US Food and Drug Administration (FDA) has approved Amgen and Allergan’s Mvasi™ (bevacizumab-awwb) as a biosimilar to Roche’s Avastin® (bevacizumab). Mvasi™ has been approved for five types of malignancy (all the eligible indications of the originator), including non-squamous non-small cell lung cancer (NSCLC), colorectal cancer, and cervical cancer in combination with chemotherapy. Mvasi™ is the first biosimilar of bevacizumab approved in a highly regulated market and the first FDA-approved biosimilar for the treatment of cancer.
The US Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Cyltezo™ (adalimumab-adbm), which is the second FDA-approved biosimilar of AbbVie’s originator Humira®. Amgen’s Amjevita® (adalimumab-atto) was the first, approved in September 2016. Cyltezo™ was approved for the full range of indications attributed to Humira®. However, Humira® will not likely see biosimilar competition in the US market for at least another couple of years because of ongoing patent litigation.
A survey of approximately 2000 US registered voters, conducted by leading pharmacy benefits manager CVS Health, has reported that 60% of respondents would accept a biosimilar substitute for a brand name biologic if they found out it would save them money. CVS Health commented: “With more Americans taking prescription medications than ever before, generic and biosimilar drugs can be an important strategy to help keep costs down without sacrificing health outcomes, especially for families managing chronic diseases or multiple health issues. Insights from consumer services like this can be a valuable source of information as we shape programs and services."
A survey of US gastroenterologists (n=103) has revealed that, if a pharmacy or managed care plan advises use of biosimilar infliximab (Inflectra®) over the originator, Remicade®, one-third of prescribers are more likely to choose a different TNF-inhibitor altogether – usually Humira® (adalimumab). However, only one in five gastroenterologists report having received such contact from a pharmacy or insurance provider. Indeed, the most reported barrier to increased use of Inflectra® is a lack of insurance mandates, though as additional TNF-inhibitor biosimilars become available, payer pressure to switch from branded biologics to their biosimilar counterparts will likely increase.
Sanofi has won tentative US Food and Drug Administration (FDA) approval for Admelog®, a follow-on biologic to Lilly’s Humalog® (insulin lispro injection), a rapid-acting human insulin analog. In a situation, which parallels that of the FDA’s recent tentative approval of Merck and Samsung Bioepis’ insulin glargine product Lusduna™ Nexvue™, approval is tentative because it is subject to the resolution of patent infringement lawsuits. Such litigation triggers a stay on final FDA approval for up to 30 months, unless a court rules in favor of the company winning the tentative approval. This scenario arises only because, in the US, follow-on versions of insulin products are not approved under the FDA’s biosimilar pathway 351(k), but instead under the pre-existing 505(b)(2) pathway. Biologic products approved via 505(b)(2) are therefore referred to as “follow-on biologics” instead of biosimilars.
The Association for Accessible Medicines (AAM) and its Biosimilars Council has announced the results of a new patient access study, Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines. According to the new analysis (which was conducted by Avalere Health*), 1.2 million US patients could gain access to biologics by 2025 as the result of biosimilar availability. The study also suggests that women, lower income, and elderly patients would particularly benefit from access to biosimilar medicines.
“One of the key challenges our healthcare system must overcome," said Bruce A. Leicher, Chair of the Biosimilars Council, “is the lack of understanding by stakeholders – including those who stand to benefit from increased access to biosimilars – of the role biosimilars can have in treatment.” The Biosimilars Council has also issued an update to its handbook, The New Frontier for Improved Access to Medicines: Biosimilars & Interchangeable Biologic Products, an educational resource for patients, policymakers, health professionals, and other stakeholders.
*Avalere’s modeling was based on the expected growth of the top seven originator biologics through 2025 and assumed a similar increase in access due to the introduction of biosimilars as has occurred in the European Union. Demographics of the current population eligible for biologic therapy was determined using the 2014 Medical Expenditure Panel Survey (MEPS).
This year’s European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain featured as many as 30 presentations on biosimilars, as well as an ESMO Special Session on biosimilars with speakers representing clinicians, nurses, patients, and the European Medicines Agency (EMA). Most notably, three companies – Amgen/Allergan, Pfizer, and Celltrion – all announced positive Phase 3 data for their biosimilar trastuzumab candidates at ESMO. Sponsor attempts to differentiate their biosimilars from competitors are starting to emerge as the competition for the lucrative Herceptin® market intensifies. Currently, Samsung Bioepis appears likely to be first to market in the EU, after Mylan and Biocon were asked to withdraw their application for approval of their trastuzumab biosimilar in order to fulfil procedural requirements linked to re-inspection of their manufacturing facility in Bengaluru, India.
Almost at the same time as the US Food and Drug Administration (FDA) announced approval of Boehringer Ingelheim’s adalimumab biosimilar, Cyltezo™, the European Medicines Agency (EMA) has announced approval of Samsung Bioepis’ version, Imraldi®. Imraldi® has been approved in the EU for all ten of Humira’s® existing indications. It is the second adalimumab biosimilar to be approved in Europe after Amgen's Amgevita™, which was approved in March. Samsung Bioepis and Amgen are not expected to start marketing their biosimilars in the EU until after October 2018, when the primary patent protection for Humira® expires. In the meantime, AbbVie continues to seek new patent-protected indications for Humira® and recently gained a license for chronic non-infectious anterior uveitis in pediatric patients, the first product approved for this indication.
Medicines for Europe has published a detailed analysis of biosimilar medicines policies across 31 European countries, detailing the status of availability, pricing systems, tendering, reimbursement, and benefit sharing for physicians, pharmacists, and patients. The review illustrates that European governments have realized that biosimilar medicines need a tailor-made policy framework and have disentangled their pricing policies from those of generic medicines. Physician-led switching and patient education remain the key drivers for increased use of biosimilar medicines. Adrian van den Hoven, Director General of Medicines for Europe, commented: “This overview shows that policy-makers need dedicated policies to provide more sustainable access to biosimilar medicines. Benefit sharing with stakeholders has proven to be the most successful approach to improving patient access and we encourage governments to learn from the best practices around Europe.”
The European Association of Hospital Pharmacists (EAHP) has published a position paper on biosimilar medicines outlining its views on the role of the hospital pharmacist as well as on naming of biosimilars, extrapolation of indications, interchangeability, switching, and substitution. The EAHP position closely follows the European Medicine Agency’s (EMA’s) perspective and expresses confidence in the EMA’s regulatory pathway for biosimilars. The paper further states that hospital pharmacists are stewards of appropriate selection, procurement, logistics, and use of medicines, as well as key players in pharmacovigilance, and consequently are ideally positioned to promote the appropriate utilization of biosimilar medicines.