News

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.

The FDA this week announced revised draft guidance that it says will help ensure that citizen petitions cannot be used by brand-name drug makers to delay the market entry of generics or biosimilars of branded products.

The Association for Accessible Medicines (AAM) and the Biosimilars Council (a division of AAM) have submitted comments to the FDA in reference to its Biosimilar Action Plan.

The study randomized and dosed 589 patients with breast cancer with either the biosimilar, the EU-licenced reference pegfilgrastim, or the US-licensed reference pegfilgrastim.

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.

This guidance document comes after AllTrials, an international initiative, launched a tracking tool in February 2018 that publicly discloses which research entities have not reported data from clinical trials.

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.

Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.

The poll found that 82% of Republicans, 92% of Democrats, and 91% of Independents polled supported legislation to limit nonmedical switching.

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

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.

From the FDA’s hearing on the Biosimilar Action Plan to European approval of the first pegfilgrastim biosimilars, September was a banner month in biosimilar regulation.

The Initiative for Medicines, Access, and Knowledge (I-MAK) report notes that 89% of these applications were filed in the United States after Humira was already on the market, and 49% were filed after the first patent expired in 2014.

According to an unofficial estimate by the Congressional Budget Office, the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028.

The Center for Biosimilars® recaps the top news for the week of September 24, 2018.

Samsung Bioepis announced that the FDA has accepted a Biologics License application (BLA) for its adalimumab biosimilar, SB5, referencing Humira.

Advocates took to Capitol Hill last week to brief lawmakers and their staff about the implications the recent CMS policy change may have on patient access to treatments.

The European Union (EU) today authorized its second pegfilgrastim biosimilar, referenced on Neulasta. The product, to be sold as Pelgraz, is indicated to reduce the duration of neutropenia, as well as the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.

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.

Notably, the study was conducted in patients with cancer, rather than in a healthy population, to generate evidence of pharmacokinetic (PK) equivalence in a scenario that reflects how the biosimilar would be used in clinical practice.

The National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.

The latest review seeking to reassure clinicians about the safety of switching their patients to biosimilars focuses on rheumatology indications.

In its report, the Congressional Budget Office (CBO) notes that it “expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law.” Additionally, CBO said that enacting the legislation would reduce federal spending on prescription drugs.

It’s no secret that hospitals and health systems continue to face pressure to improve patient outcomes while managing the total cost of care. Now, biosimilars present an opportunity to address both needs. They are clinically equivalent to reference biologic products and offer potentially significant savings. Yet many hospitals struggle to change their formularies and physician preferences for these medications.

A United Kingdom court has ruled in favor of the National Health Service, allowing the health system to provide intravitreal injections of the anti–vascular endothelial growth factor agent bevacizumab to patients with age-related macular degeneration (AMD).

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.

Senator Dick Durbin, D-Illinois, a co-sponsor of the amendment, placed blame on pharmaceutical companies for using their influence to block the measure.

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.

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.