News

New research suggests that inhibiting platelet-derived growth factor (PDGF), which regulates cell growth and division, could help overcome resistance to anti–vascular endothelial growth factor treatment in glioblastoma multiforme.

“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.

Reimbursement of a second biosimilar infliximab could provide welcome savings in a health system struggling with high drug costs.

“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.”

Hospira had asked the court for a judgment that producing batches of a biosimilar product is an activity protected by safe harbor provisions, that Hospira did not infringe on the ’298 patent (which Hospira claims is invalid), and that damages owed to Amgen not exceed $1.5 million per batch of the drug (if those batches were later sold). Alternatively, it sought a new trial in the case.

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.

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the organization encourages the FDA to reconsider.

It has now been more than 100 days since the Trump administration released the American Patients First blueprint, an effort to lower ever-increasing drug prices in the United States.

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.

The Center for Biosimilars® recaps the top news for the week of August 20, 2018.

The FDA recently sent a warning letter to Kyowa Hakko Bio, the parent company of biosimilar developer Kyowa Kirin Biologics, in reference to an inspection of manufacturing plant, Hofu-shi, in Yamaguchi, Japan.

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.

Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.

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.

Because patients with rheumatoid arthritis may have compromised manual dexterity, they may have challenges with self-administering their biologic therapies. In the case of etanercept, which is typically administered once per week, device design that prioritizes ease of use can help improve patient adherence to treatment regimens.

The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.

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.

The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.

The National Institute for Health and Care Excellence (NICE) evidence reviewers considered a biosimilar discount of 70% to 90% off the reference trastuzumab’s price at a 90% to a 100% market share, and the Cancer Drugs Fund provided the committee with confidential information on the weighted average price and market share for available biosimilar trastuzumab products.

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.

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted the company positive scientific advice to begin a phase 3 clinical trial of its proposed trastuzumab biosimilar, JHL1188.

Although the policy change was intended to cut out-of-pocket drug costs for patients, a number of organizations, including the American College of Rheumatology (ACR), have argued that step therapy can be harmful to patients with chronic conditions. On Wednesday, ACR met with HHS Secretary Alex Azar to discuss their concerns.

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.

The Center for Biosimilars® recaps the top news for the week of August 13, 2018.

As biosimilar competition nears for Roche and its subsidiary, Genentech, a new WARN notice in the state of California disclosed that Genentech is set to lay off 223 employees from a local plant beginning August 31, 2018.