News

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.

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.

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.

Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.

In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.

CVS Caremark will allow clients to exclude any drug launched at a price greater than $100,000 per quality-adjusted life year from their plans.

Now that multiple biosimilars of adalimumab (Humira) are approved, though none have launched in the United States or European Union, attention is turning toward the next wave of biosimilar candidates.

While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine.

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.