News

Last year, the average rise of per employee cost of specialty drugs was 12%, with oncology making up the largest category.

According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.

Magellan Rx Management, a pharmacy benefit manager (PBM), said today that its biosimilar management program has resulted in strong biosimilar uptake and significant drug cost savings for health plan organizations during its first year.

The FDA is committing a serious policy misstep that puts this progress at risk by adding a random, meaningless 4-letter suffix to the names of biosimilar products that are approved to treat the same diseases as their reference biologics.

The Community Oncology Alliance (COA) recently released a position statement about biosimilars, saying it will work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps, given the burdensome cost of cancer care.

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.

The new assessment, says the Institute for Clinical and Economic Review (ICER), is intended to incorporate data that have emerged since the organization reviewed rheumatoid arthritis (RA) treatments in 2017, including data related to biosimilar infliximab, Inflectra.

The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.

Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

A new paper describes the process of assessing the analytical and functional similarity of EU- and US-licensed reference trastuzumab and Amgen's ABP 980, Kanjinti.

Genor Biopharma, a China-based drug developer that is engaged in development of a number of biosimilars, has completed a phase 1 study of a proposed infliximab biosimilar, GB242, referencing Remicade.

While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.

The Center for Biosimilars® recaps the top news for the week of April 8, 2019.

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.

Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.

During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.

Nordic countries with highly competitive public tenders are among the markets that have seen the greatest success with adopting biosimilars and reaping their cost-saving rewards. Yet Sweden, unlike its neighbors, has decentralized healthcare budgets and policies in its 21 county councils, and has seen more variable uptake of biosimilars.

Before the Senate Finance Committee, pharmacy benefit managers said legal issues, not their actions, were to blame for keeping biosimilars from reaching US patients.

In its announcement, the drug maker said that its Udenyca sales are expected to be in the range of $36 million to $38 million.

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

An advocacy group for patients with breast cancer in Canada recently published a series of recommendations after convening roundtable discussions with both patients and providers about their knowledge of biosimilars.

Pfizer has launched its biosimilar trastuzumab, Trazimera, in Spain. The biosimilar became available to Spanish patients with early and locally advanced or metastatic HER2-positive breast cancer and HER2-positive metastatic gastric cancer on April 1, 2019.

This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.

The study is an open-label extension of a phase 3 trial that included 68 weeks of treatment with the biosimilar adalimumab, Amjevita, followed by an assessment visit at week 70 and an end-of-study visit at week 72.

Intravenous golimumab and infliximab are both widely used in the treatment of rheumatoid arthritis (RA) in the United States, though these anti–tumor necrosis factor agents have markedly different dosing recommendations; patients who receive golimumab may receive 7 infusions during year 1, while patients who receive infliximab may receive between 8 and 14 infusions during year 1.

Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.

The FDA this week finalized a 2016 draft guidance that explains when the agency deems a Risk Evaluation and Mitigation Strategy (REMS) program to be necessary for a given drug.

The Center for Biosimilars® recaps the top news for the week of April 1, 2019.

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

Next week, researchers from around the globe will gather in Geneva, Switzerland, for the 2019 European Lung Cancer Congress. During the meeting, multiple research teams will discuss new findings from research into the use of bevacizumab—which now has approved biosimilars that promise cost savings and expanded patient access—in nonsquamous non–small-cell lung cancer (NSCLC).