Kelly Davio

January 21, 2019

In 2018, Green Shield Canada launched its pilot Biosimilar Transition Program, through 3 plan sponsors, under which patients already receiving biologics were switched to biosimilars. Now that the pilot is complete, the payer is calling the program a success.

January 21, 2019

The package leaflet provided to a patient with any drug product includes crucial information about a given therapy that can increase adherence and appropriate use of the product. To help make these leaflets as useful as possible for patients, in 2009, the European Commission published a new guideline on the readability of these labels with the aim of making them easier for patients to understand.

January 18, 2019

A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.

January 17, 2019

When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.

January 17, 2019

After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.

January 16, 2019

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”

January 16, 2019

Samsung Bioepis’ biosimilar adalimumab, SB5, has been approved in the European Union under the name Imraldi on the basis of clinical studies including a phase 3 study in patients with rheumatoid arthritis. Now that the biosimilar has begun to make its way to EU patients, investigators are publishing new data on other key facets of the product, including its shelf life and device usability.

January 15, 2019

A representative from Pfizer confirmed to The Center for Biosimilars® that the company has terminated 5 of its preclinical biosimilar programs after the results of the company’s annual investment review.

January 15, 2019

The House Committee on Oversight and Reform has launched a wide-ranging investigation into prescription drug pricing in the United States.

January 14, 2019

In May 2018, as part of the Trump administration’s blueprint to reduce drug costs for American patients, HHS proposed shifting coverage of some Medicare Part B drugs to Medicare Part D. However, a new study, published today in JAMA Internal Medicine, finds that shifting reimbursement of these drugs could increase out-of-pocket spending for some Medicare beneficiaries.