News

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

Cost-effectiveness evidence has come to play a prominent role in decisions regarding the approval of expensive biologic treatments, such as those for psoriatic arthritis (PA). However, cost-effectiveness evidence for PA treatments has been difficult to develop because of the lack of a robust evidence base.

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.

The National Academy for State Health Policy (NASHP), a non-profit, non-partisan academy of state health policymakers, reports the following successful 2017 drug pricing initiatives passed at the state level.

The approval for adalimumab-adbm comes a year after the first adalimumab biosimilar, by Amgen, was approved in September of 2016.

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

Providing prophylactic treatment with granulocyte-colony stimulating factor to patients receiving chemotherapy may yield better chemotherapy-induced neutropenia, febrile neutropenia, and related hospitalization outcomes if patients receive prophylaxis at levels above guideline recommendations, according to a recent study.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

Genentech, a member of Roche Group, has announced that the FDA has accepted its Biologics License Application and granted priority review for emicizumab, a once-weekly subcutaneous prophylaxis for adults, adolescents, and children with hemophilia A who have factor VIII inhibitors.

The FDA has signed a new confidentiality agreement with the European Commission (EC) and the European Medicines Agency (EMA). The agreement will allow the FDA to share with the EC and EMA nonpublic, commercially confidential information (including trade secrets) related to inspections.

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

Coherus BioSciences has announced that it plans to raise up to $150 million in a 2-tranche private placement deal with Temasek.

A study published in the British Journal of Clinical Pharmacology demonstrated the bioequivalence of GP2015, a biosimilar etanercept treatment (Sandoz’s Erelzi), when delivered with an auto-injector and when delivered with pre-filled syringe in patients across a variety of body weights.

The White House confirmed last week that it will continue to make cost-sharing reduction (CSR) payments for the month of August. The Trump administration has been making decisions on whether to continue to fund CSRs on a monthly basis, and had previously suggested that it might soon put an end to CSRs.

A new paper, accepted for publication in Diabetes, Obesity and Metabolism, describes 2 recent studies that demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293, an insulin glargine follow-on being developed by Merck (who funded the studies), and the originator insulin glargine (Lantus).

Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.

Drug maker Alexion has announced 3 new US patents for its eculizumab (Soliris), a first-in-class monoclonal antibody that specifically binds to the complement protein C5. Additionally, the drug gained the European Commission’s approval for the treatment of refractory generalized myasthenia gravis.

Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.

Sandoz announced today that it has launched its etanercept biosimilar (Erelzi) in Canada.

Biosimilar developer Samsung Bioepis announced today that it has signed a collaborative agreement with Takeda to co-develop multiple novel biologic drugs that will target currently unmet needs.

A recent report examined the products and projects targeting diabetes and diabetes-related complications are in the current biopharmaceutical pipeline. Our infographic details the key findings.

Pharmacy Benefit Manager CVS Health, which has over 90 million members, has released the results of a survey it conducted of approximately 2000 people in the United States concerning patient perceptions of generic and biosimilar medications.

A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.

Recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and its long-acting pegylated form, pegfilgrastim, are widely used to reduce the risk of chemotherapy-induced neutropenia, but to date, no pegfilgrastim biosimilar has been approved in highly regulated markets such as Europe, Japan, and the United States.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 2017.

Drug maker Biogen recently announced that it has developed a framework to predict outcomes in specific patient populations taking its drugs in order to arrive at the best value-based pricing agreements with payers.

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

Treatment guidelines for ovarian and cervical cancer recommend the use of the angiogenesis inhibitor bevacizumab (Avastin), but patient access to this medication and other angiogenesis inhibitors is limited.

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.