News

Perhaps not surprisingly, officials from generic drug companies, reference product companies, the FDA, and the Federal Trade Commission (FTC) have different opinions about the usefulness of various actions the federal government has taken to prevent abuses of risk evaluation and mitigation strategies (REMS), according to a recently released Government Accounting Office (GAO) report.

This month, the European Commission’s Pharmaceutical Committee, part of the Health and Food Safety Directorate-General, updated EU member states as to the results of a targeted consultation it undertook in 2018 on a specific type of duplicate marketing authorization applications (MAAs) for originator biologics and their potential impact on biosimilars.

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

With more choices available in 2020 for Medicare stand-alone Part D drug plans, beneficiaries should compare choices, especially if they are not low income or on specialty drugs or drugs not on the payer’s formulary, according to a new analysis.

This week, a study from Spain retrospectively compared direct costs of intravenous and subcutaneous reference rituximab in the setting of lymphoma, taking into consideration drug costs, pharmacy costs, and chair time-related costs at a single center in 2017. They also conducted the same analysis using the costs of biosimilar rituximab.

Samsung Bioepis announced Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB8, a proposed bevacizumab biosimilar referencing Avastin. The biosimilar developer submitted the BLA in September.

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).

While much attention over the past few weeks has been on the US biosimilars market, with its recent approvals and product launches, Canada has also been making strides in its own biosimilars experience.

The field of biosimilar contenders for anti–vascular endothelial growth factor (anti-VEGF) therapies is taking shape, with biosimilar developer Coherus seeking to launch its ranibizumab biosimilar in 2021 and Samsung Bioepis having reached a commercialization agreement for 2 biosimilar anti-VEGFs of its own. Last week, a study published in JAMA Ophthalmology supported the use of anti-VEGF agents in wet age-related macular degeneration (AMD), saying that, though these drugs are costly, they may provide substantial economic value to both patients and society.

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

Novartis has confirmed in an email to The Center for Biosimilars® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

The AARP Public Policy Institute has released a new Rx Price Watch report showing that, last year, the retail prices of 267 brand-name drugs that are commonly used by older Americans rose by an average of 5.8%—more than twice the general rate of inflation, which was 2.4%.

A House subcommittee voted unanimously Thursday to send a bill intended to stop sham citizen petitions from clogging the FDA’s approval process for generic drugs under the section 505 pathway to the full Energy and Commerce Committee.

The Center for Biosimilars® recaps the top stories for the week of November 11, 2019.

Organizations reacted this week to news that CMS is raising Part B premiums with a variety of opinions, as CMS blamed rising drug prices for the increase.

The World Health Organization (WHO) this week announced its pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured insulin and insulin biosimilars for type 1 and type 2 diabetes in low- and middle-income countries.

Today in the European Union, we can be proud and celebrate the fact that in 28 EU Member States, biosimilar medicines are in use, and competition in the biological medicines field has consistently brought value for patients and healthcare communities. In general, broader access (more patients treated) is an immediate consequence of biosimilar competition, and earlier access to treatment (where clinically appropriate) has been observed in a number of countries.

Researchers report that there were no differences in visual acuity letter score (VALS) and central subfield thickness (CST) outcomes at month 24 between patients treated with bevacizumab and those treated with aflibercept in the SCORE2 study.

The high cost of healthcare is putting a strain on employers who provide health insurance coverage to their employees, and prescription drug prices are now front and center in the push to make coverage more affordable to provide to American workers.

Biosimilars have made headlines for their potential to offer a more affordable treatment option to patients in need of biologics. Today, with the increasing knowledge and identification of rare diseases, biosimilars have a renewed purpose in healthcare; they represent a significant opportunity to fulfill the unmet medical needs of rare disease patients at a much lower cost.

The Center for Biosimilars® recaps the top stories for the week of November 4, 2019.

Among all respondents, 53% of beneficiaries reported having had a serious problem paying a medical bill of any kind. Thirty percent of respondents said prescription drugs created the largest burden.

Teva and Celltrion have announced the launch of their biosimilar rituximab, Truxima, in the United States. The product is being offered at a 10% discount to the list price of reference product, Rituxan. The product will begin to reach patients on November 11.

This week, multiple biosimilar developers announced major moves forward for their businesses, with Coherus BioSciences making a new acquisition, Celltrion reporting continued growth for its business, Bio-Thera Solutions gaining the first-ever approval of an adalimumab biosimilar from China’s National Medical Products Administration, and Alvotech and Stada entering into a 7-biosimilar partnership in Europe.

Sanofi released phase 3 results this week for its long-acting insulin glargine (Toujeo) when used in pediatric patients with type 1 diabetes aged 6 to 17.

Samsung Bioepis announced Wednesday that it has entered into a new commercialization agreement with partner Biogen for 2 ophthalmology biosimilars that are currently in development.

The FDA has issued an establishment inspection report (EIR) for Biocon’s Bengaluru facility, where the drug maker manufactures biosimilars, and the FDA’s inspection of the facility, which took place during August 2019, is now closed.

A recent study from Romania examined the efficacy and safety of biosimilar etanercept SB4 (Benepali) compared to originator etanercept in a real-life cohort of patients with rheumatoid arthritis (RA).

The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.

The biggest cost difference in filgrastim administrations was seen in the commercially insured population after the launch of a biosimilar, according to a study published Monday in Health Affairs.