News

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.

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

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.

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.

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.”

Senators Amy Klobuchar (D-Minnesota) and Chuck Grassley (R-Iowa) recently reintroduced bipartisan legislation aimed at bringing down prescription drug costs.

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.

Bio-Thera announced yesterday that it has partnered with Cipla Limited in a licensing agreement for its potential bevacizumab biosimilar, BAT1706, referenced on Avastin.

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.

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

Last week, Senator Bernie Sanders, I-Vermont, and Representative Elijah Cummings, D-Maryland, introduced legislation comprising 3 bills to curb the cost of prescription drugs.

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.

The body of evidence demonstrating the safety and efficacy of biosimilar infliximab, CT-P13 (Inflectra, Remsima), is growing, particularly in the extrapolated indication of inflammatory bowel disease (IBD). This month saw the publication of 2 new studies that provided reassuring data on CT-P13, one of which focused on switching pediatric patients with IBD to CT-P13, and the second of which explored switching to the reference infliximab from the biosimilar in adults with IBD.

During this year’s investment symposium, held in San Francisco, California, from January 7-10, biosimilars featured prominently in drug makers’ and regulators’ visions for 2019 and beyond. Here are 7 key takeaways from the conference’s biosimilars presentations.

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.

Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.

The Center for Biosimilars® recaps the top news for the week of January 7, 2019.

This week, investigators published the results of the MAPLE study, a phase 3 trial of Amgen’s bevacizumab in comparison with the reference, Avastin, in patients with advance nonsquamous non–small cell lung cancer who were also receiving first-line chemotherapy with carboplatin and paclitaxel.

Swedish biotechnology company Xbrane Biopharma recently announced that it has submitted its first national Clinical Trial Application to the FDA seeking permission to begin the Xplore trial.

Following promises of halts to increases in drug prices in 2018, pharmaceutical makers began January by raising the prices of more than 250 drugs. Now, HHS Secretary Alex Azar is calling on companies to bring their list prices back down.

While 63% of respondents who had switched to a biosimilar said that they had been consulted in some form prior to the transition, 37% said that they had not been consulted (despite the fact that National Health Service guidelines require the patient to be consulted about such a switch).

The fact that cost growth is driven largely by older products and not by new blockbuster therapies “is particularly important,” write the authors, “because in the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes. However, rising costs due to inflation do not reflect improved value for patients.”

The Community Oncology Alliance (COA) recently formed a standing Biosimilars Committee for which The Center for Biosimilars® advisory board member, Kashyap Patel, MD, a practicing medical oncologist at Carolina Blood and Cancer Care in South Carolina, was named chair alongside co-chairs immediate past president of COA, Jeff Vacirca MD, FACP, and Michael Diaz, MD, incoming COA president.

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced that it will partner with Chinese biopharmaceutical company 3SBio to develop and commercialize multiple biosimilars in mainland China.

This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.

In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.

Coherus BioSciences has confirmed that it has launched its pegfilgrastim biosimilar, Udenyca, in the United States market.

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.