News

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts.

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.

Investigators said the English health care system has realized only a sliver of the potential savings potential from biosimilar insulin glargine and that uptake is widely uneven across health care centers.

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

Here are the top 5 biosimilars articles for the week of June 8, 2020.

In search of effective treatments for patients hospitalized with coronavirus disease 2019 (COVID-19), investigators will test an infliximab biosimilar (Remsima, CT-P13). They believe it may help to control cytokine release syndrome, which is associated with COVID-19.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

As the United States struggles to increase biosimilar uptake, a researcher believes that establishing a shared savings model for Medicare Part B drugs could provide valuable insight into how changing reimbursement patterns could increase utilization.

Canada Health has approved the launch of Sandoz' pegfilgrastim and rituximab biosimilars.

Biosimilar discounts to reference products have improved over time, but they are deeper in some categories than others.

Xbrane Biopharma said it needs a new lab and headquarters because of rapid growth and ambitious plans for biosimilar development.

As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).

The biosimilar market is headed for a fork in the road, and the road taken will lead to savings and access or less competition and stiffer regulation.

Mylan and Lupin have received market authorization for their etanercept biosimilar (Nepexto, YLB113) in Europe for all indications of the reference product.

Here are the top 5 biosimilars articles for the week of June 1, 2020.

Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. An ongoing process may fix that.

Recognizing that oncology practices are struggling with the pandemic, the Center for Medicare and Medicaid Innovation has eased some performance requirements.

Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.

In a settlement announced via a Securities and Exchange Commission filing, Alexion said it had settled with Amgen over eculizumab patent disputes, allowing Amgen to bring a competing biosimilar to market in 2025.

Although the coronavirus disease 2019 pandemic continues to hamper the pharmaceutical industry, it hasn’t stopped companies from continuing to make deals, seek approvals, and conclude clinical trials.

After some delay, Revance and Mylan have decided to push forward with an FDA application for an onabotulinumtoxinA (Botox) biosimilar.

Shanghai Henlius Biotech received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization in 2 to 3 months.

Here are the top 5 biosimilars articles for the week of May 25, 2020.

Fresenius Kabi has tapped pharmaceuticals distribution company medac to amplify sales of its pegfilgrastim biosimilar in Germany.

Fresenius Kabi USA announced that the FDA has accepted its biologics license application for the pegfilgrastim biosimilar candidate MSB11455.

Among the briefs filed in defense of the Affordable Care Act and, with it, the Biologics Price Competition and Innovation Act (BPCIA), is one from the Association for Accessible Medicines, which argues the BPCIA is vital to biosimilars market development.

CMS announced that its Part D Senior Savings Model designed to cut insulin costs for struggling Medicare beneficiaries is attracting broad insurer participation, indicating high potential for success.

Swedish researchers analyzing more than 10 years of data found that Omnitrope (biosimilar recombinant human growth hormone) is safe and effective in treating adult and pediatric patients with growth hormone deficiencies.