The Center for Biosimilars Staff

Eli Lilly and Company announced this week that it has made a lower-cost insulin lispro injection available in pharmacies. The company said that the authorized version carries a list price ($137.35 per vial and $265.20 for a package of 5 pens) that is 50% lower than that of the brand-name Humalog injection.

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologics, are often restricted to cases in which patients fail to respond adequately to methotrexate or other conventional disease-modifying antirheumatic drugs, which may be difficult for some patients to tolerate.

Last week, CMS issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B.

During this week’s meeting of the International Society for Pharmacoeconomic and Outcomes Research, held from May 18 to 22 in New Orleans, Louisiana, researchers presented findings on both the patient attitudes toward granulocyte colony-stimulating factor (G-CSF) therapies and their effectiveness in the prophylaxis of febrile neutropenia.

NeuClone announced yesterday that it will initiate a phase 1 clinical trial of its ustekinumab biosimilar, referencing Stelara, in the second half of 2019. Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

AbbVie announced today that it has settled its patent litigation with Boehringer Ingelheim over adalimumab.

In 2018, The Generic Biosimilar Medicines Association (GBMA) was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan. Now, the GBMA has launched an educational hub.

Biosimilar developer Biocon said this week that it will share in the global profits of Hulio, an adalimumab biosimilar referencing Humira, that is licensed to Mylan by Fujifilm Kyowa Kirin Biologics.

China-based biosimilar developer Innovent and Eli Lilly and Company announced this week that 2 studies of IBI301, a proposed rituximab biosimilar being jointly developed by the 2 drug makers, met their primary end points.

Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.

The authors concluded that the physiochemical and biological analyses demonstrated that the biosimilar is not affected by reconstitution, dilution, and extended storage in infusion bags. These findings, they write, provide added reassurance to healthcare providers that the biosimilar is safe and effective under extended in-use conditions.

On Monday, the Seoul Central District Prosecutor’s Office in the Republic of Korea arrested an executive and another employee at biosimilar developer Samsung Bioepis for falsifying and destroying evidence and for violating audit law.

The market for orphan drugs is set to grow over the next 4 years, a pharmaceutical report says.

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, has reported the results of a clinical study of its proposed bevacizumab biosimilar, BAT1706, referencing Avastin.

During the first quarter of 2019, Samsung Bioepis’ biosimilars revenue increased to $175 million, up from $128 million in the first quarter of 2018. Those numbers, say Biogen, are driven by the launch of biosimilar adalimumab, Imraldi.

Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.

National guidelines and reimbursement rules are likely to be key drivers of disparities; in some countries, biologics are not reimbursed at all, while in others, patients may need to have high disease activity levels, or may need to fail numerous small-molecule drugs before gaining access to biologics. Differences in cost-effectiveness thresholds used in Health Technology Assessments may also be a factor.

After treatment withdrawal, 58.3% of patients with ankylosing spondylitis (AS) had relapsed. Half of the relapses appeared within 6 months.

Fuji Pharma will market Alvotech’s biosimilar ustekinumab in Japan, the companies announced this month.

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.

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.

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.