Kelly Davio

The State of California has filed suit against drug maker AbbVie, alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name adalimumab, Humira, and used a network of registered nurses to mislead patients about the risks associated with the drug.

The bill, introduced in March 2018 by Senator Susan Collins, R-Maine—together with Senators Claire McCaskill, D-Missouri, and Debbie Stabenow, D-Michigan—eliminates so-called “gag clauses” that prevent pharmacies from telling consumers whether they could spend less on their medication by paying out-of-pocket.

The improved efficacy of a biologic drug in combination with a conventional treatment in rheumatoid arthritis (RA) has been well demonstrated, but some biologic-naive patients are unable to tolerate drugs such as methotrexate. Limited data are available about which biologic to select for monotherapy in such patients, however.

Two pivotal studies of biosimilar epoetin alfa (Retacrit) versus its reference (Epogen) in patients undergoing hemodialysis have shown that the biosimilar and the originator have comparable safety and efficacy. In the phase 3b PIEDA (Phase 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm) study, investigators sought to further investigate how switching from the reference to the biosimilar affects maintenance of hemoglobin levels when using an erythropoiesis-stimulating agent dosing algorithm.

The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

“Biosimilars offer incredible health and economic opportunities in the United States, but unless substantial barriers are surmounted, these opportunities will not be fully realized,” say the report's authors.

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

In a session held at the GRx+Biosims 2018 conference in Baltimore, Maryland, Gillian Woollett, MD, DPhil, senior vice president of Avalere Health, and Michelle Lee-Bourner, head of regulatory affairs for biologics and respiratory products at Mylan, discussed experience with and expectations for biosimilar regulation.

The European Union already has far more approved biosimilars—45 products referencing 15 medicines—than does the United States, but as a newly released report from IQVIA states, the number of European biosimilars available today represents just a fraction of what the market is expected to contain in the coming years, raising questions about the sustainability of the market.

Writing in the European Medical Journal, Anna La Noce, MD, PhD, and Marcin Ernst, MD, MBA, explain that much confusion about switching between biosimilars and reference products in the United States versus in the European Union arises from different uses of the term “interchangeability.”

Two research letters, published concurrently in the Journal of the American Medical Association, focused on biosimilars and their role in the Medicare population.

Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.

IgG4-related disease (IgG4-RD), a systemic disease that can affect any part of the body and can involve fibrosis, irreversible organ damage, and secondary amyloidosis, is a rare immune-mediated condition often treated with corticosteroids or immunosuppressive drugs. The pathogenesis of the disease is not clear, but treatment with B-cell depletion therapy, in the form of rituximab, has shown positive results in some patients.

August 2018 saw a variety of developments in the policy landscape for biosimilars, both in the United States and worldwide.

“This comes down to the assiduous care you must do for any clinical studies using human subjects…you don’t experiment on human beings unless you’re really going to learn something,” said Gillian R. Woollett, MA, DPhil, senior vice president of Avalere Health.

“Misleading statements...and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read Pfizer's citizen petition.

The World Health Organization (WHO) has published a new report on reimbursement policies in Europe that provides a comparative review and analysis of the policies employed by 45 different European countries, and says that promoting the uptake of lower-priced medicines such as generics and biosimilars will “facilitate efficiency gains without disadvantaging patients.”

Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.

There was a significant difference observed in pain scores between pediatric patients receiving pegfilgrastim versus those receiving filgrastim after allogenic hematopoietic stem cell transplantation.

The government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted.

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that 2 adalimumab biosimilars be treated as equivalent to the reference adalimumab, Humira, and be subject to substitution at the pharmacy level.

During the 34th International Conference on Pharamcoepidemiology and Therapeutic Risk Management, taking place from August 22 to 26 in Prague, Czech Republic, researchers will present findings that contrast the cost savings made possible by biosimilars in the US and European contexts.

Agalsidase beta (Fabrazyme), the first Fabry disease-specific therapy to be approved by the FDA, effectively reduces globotriaosylceramide deposits. However, the drug comes with a high price tag of approximately $300,000 per patient per year, and has been subject to shortages due to manufacturing issues.

Alexion’s existing C5 complement inhibitor, targeted by biosimilar developers, is used to treat patients with paroxysmal nocturnal hemoglobinuria, but the biologic must be administered every 2 weeks versus ALXN1210’s proposed 8-week intravenous dosing schedule.

The advent of biosimilar etanercept, Benepali, in the United Kingdom has provided a significant opportunity for cost savings, given the biosimilar’s lower price than the reference Enbrel. As such, hospitals have been undertaking nonmedical switches to the biosimilar in order to benefit from these savings. During the British Society for Rheumatology 2018 Annual Conference, held in May in Liverpool, United Kingdom, investigators reported on the results of these switches, both on the financial wellbeing of the health system and on patients.

“It is now time to reassess whether the current clinical development paradigm really makes sense from a scientific and economic perspective while millions of patients still have limited or, more often, no access to life-changing/life-saving [monoclonal antibodies],” writes Francois-Xavier Frapaise, MD, PhD.

Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira, shares similar efficacy, safety, and immunogenicity profiles with its reference at 26 weeks of treatment, new research reports.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency says that it is taking steps to ensure that clinical trials taking place in the country will not be adversely affected by Brexit.

Eli Lilly says that it will not comply with a 2017 California law on drug pricing, and now the state senator who sponsored the bill is hitting back against the drug manufacturer, calling the company’s activities to promote its diabetes programs “disingenuous and offensive.”

In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.