The Center for Biosimilars Staff

May 23, 2019

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.

May 22, 2019

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.

May 21, 2019

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.

May 20, 2019

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

May 18, 2019

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.

May 16, 2019

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.

May 15, 2019

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.

May 14, 2019

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.

May 14, 2019

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

May 13, 2019

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.