News

The FDA has approved Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz).

With the launch of some of the most highly anticipated products thus far in the biosimilar experience, and with the release of key new data on multiple biosimilar products, October 2018 was a memorable month for biosimilar stakeholders.

The Salt Lake Tribune is reporting that public employees in the state of Utah could be paid by their insurance plan to fill prescriptions for high-cost drugs in Mexico instead of in their local pharmacies.

In recent years, spending on specialty drugs, including spending on a proliferation of orphan drugs that treat rare diseases, has raised concerns about sustainability of the healthcare system.

A recent population-based study examined the prescribing and utilization of CT-P13 versus the reference infliximab in infliximab-naïve patients and found that discontinuation and switching were more common among patients who began therapy with the biosimilar.

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

The arrival of biosimilar adalimumab in European markets has been cause for enthusiasm among those seeking greater patient access and lower costs for the treatment of rheumatoid arthritis (RA). However, AbbVie (maker of the reference adalimumab, Humira) has revealed that its oral Janus kinase inhibitor, upadacitinib, outperformed both placebo and adalimumab in a phase 3 study.

While real-world data, such as those derived from the NOR-SWITCH study, have been reassuring about the feasibility of switching patients with inflammatory diseases from reference infliximab (Remicade) to biosimilar CT-P13 (sold as Inflectra and Remsima), some ambiguous data in patients with inflammatory bowel disease (IBD) have raised questions among clinicians about switching in the indications of Crohn disease and ulcerative colitis.

NeuClone has announced the start of its first-in-human trial of a trastuzumab biosimilar in a phase 1 trial.

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.

Yesterday, the Trump administration released a new plan aimed at reducing Medicare’s costs for prescription drugs. Under the plan, CMS would be able to set its prices for some drugs, including biologics, based on the prices paid in other nations. Since the announcement, several stakeholders have spoken out about the proposed change.

On Thursday, the Trump administration unveiled a new plan that it hopes will reduce Medicare’s costs for prescription drugs. Under the plan, announced by President Donald Trump in a speech made at HHS, CMS could set its prices for some drugs—including high-cost biologics—based on the prices paid in other nations.

The Center for Biosimilars® recaps the top news for the week of October 22, 2018.

This month, Maryland’s Attorney General Brian Frosh petitioned the Supreme Court to uphold the “first-in-the-nation” law against drug price-gouging.

China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody.

On Friday, Mylan announced that it has launched its biosimilar adalimumab, Hulio, in the European Union. Hulio’s entrance into the marketplace brings the number of available biosimilar adalimumab therapies to 4.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

New research from Avalere suggests that moving Part B drugs into Part D could result in higher out-of-pocket costs for beneficiaries with rheumatoid arthritis (RA) unless policy changes are made to reduce Part D cost sharing.

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.

The Center for Biosimilars® recaps the top news for the week of October 15, 2018.

A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.

This week, the insurer rolled out some of the changes it will be implementing in its Medicare Advantage (MA) plans as of January 1, 2019.

Ireland’s Medicines Management Program (MMP), a body that promotes cost-effective drug prescribing, has opened a consultation related to its roadmap for prescribing best-value biologics in the Irish healthcare setting. Under the roadmap, the MMP will review the use of currently reimbursed anti–tumor necrosis factor (TNF) therapies, which represent the highest-expenditure category for Ireland’s reimbursement plan.

One day after Sandoz and Amgen announced European launches of their biosimilar adalimumab products referencing Humira, Samsung Bioepis announced that it has launched its own biosimilar, Imraldi.

“When we change the rules, the market players will reorganize their businesses to fit the new world. And it will be a very different world for American drug pricing," said HHS Secretary Alex Azar.

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom, and Amgen announced that it will begin making its Amgevita available in multiple European markets.

October 16 marks European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.

According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.