The Center for Biosimilars Staff

The paper reports findings from a study that used retrospective data from a single center in Poland from 2009 to 2014. Records from a total of 104 patients, each of whom received infliximab, etanercept, or adalimumab under the National Health Fund, were assessed.

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

Infliximab accounts for substantial drug spending in the United States, and dose rounding has become a common practice at many facilities as a way to avoid wasting vials that have only been partially used. However, many institutions do not have standardized approaches to rounding doses, and because infliximab requires a weight-based dose, rounding becomes even more complex.

Using electronic health records (EHRs) to create a learning healthcare system, say the authors, can enable researchers to generate new knowledge that will accrue benefits to future generations of patients.

The United Kingdom has opened a consultation on provisions that it hopes will ensure the supply of medicines in the event that no agreement can be made between the United Kingdom and the European Union before the Brexit deadline.

Swedish biotechnology company Xbrane Biopharma today announced that its ranibizumab biosimilar, referencing Lucentis, demonstrated an equivalent pharmacokinetic (PK) profile and equivalent tolerability to its reference in an in vivo study.

Dong-A ST, a biosimilar developer based in the Republic of Korea, has, together with Sanwa Kagaku Kenkyusho, filed for Japanese regulatory approval of DA-3880, a darbepoetin alfa biosimilar referencing Aranesp.

In explaining why some patients who switch to biosimilars from reference biologics discontinue their therapy at a higher rate than those who remain on a therapy without interruption, some authors have referenced the so-called “nocebo” effect. This effect, whereby a patient experiences disease worsening or adverse events due to negative beliefs about a drug, has been controversial, however, and not all clinicians agree that the effect is to blame for differences in discontinuation.

The product is the first pegfilgrastim biosimilar to be authorized by the European Commission and the first Coherus product to be cleared by a regulatory authority.

A recently published study between the biosimilar and the reference rituximab, MabThera, demonstrated that the biosimilar was noninferior to the reference in terms of both efficacy and safety in treating chronic lymphocytic leukemia (CLL).

The risk evaluation and mitigation strategy program for clozapine allows for patients to receive clozapine—even in the setting of moderate to severe neutropenia—if the benefit to psychiatric treatment outweighs the risk of recurrent neutropenia. However, literature that can guide appropriate treatment for such patients is limited. A recently published case report suggests that using filgrastim to control leukopenia and neutropenia could allow patients to continue to receive clozapine without interruption.

Brazil benefits from a program, known as the Partnership for Productive Development, that brings together government and the private sector to develop strategic products of interest to the Brazilian health system—including biosimilars of high-cost biologics that account for approximately half of annual drug spending.

Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.

On September 13, the European Medicines Agency (EMA) published new, patient-focused materials that aim to make patients aware of biosimilar medicines and how the EMA assures that they are as safe and effective as reference biologics.

Only 38% of Americans say that they are either very confident or somewhat confident that the administration’s plan will result in paying less for their prescription drugs.

Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.

Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries.

While both the biosimilar filgrastim and biosimilar pegfilgrastim were effective in reducing the incidence of neutropenia, adverse events related to granulocyte-colony stimulating factor therapy were significantly higher in patients who received pegfilgrastim.

Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.

Celltrion announced last week that it has completed its phase 3 clinical trial for subcutaneous biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in other territories as Remsima), and that it will now prepare a marketing authorization application for submission to the European Medicines Agency.

Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.

Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”

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.

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

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.

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 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.

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.

This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.

Celltrion has announced that it is ready to begin a phase 3 trial of its proposed bevacizumab biosimilar, CT-P16. The multicenter study will begin in Portugal and will eventually include approximately 150 sites in 20 nations in Europe, Asia, and South America.