News

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.

Daewon Pharmaceutical has launched Terrosa, a teriparatide biosimilar, on the Republic of Korea market, after signing a domestic sales agreement with Richter-Helm Biotec. The drug is intended for the treatment of osteoporosis.

Ruth O’Regan, of the University of Wisconsin Carbone Cancer Center, discusses improving the patient discussion on biosimilars, in an interview.

On the heels of positive clinical studies, Fresenius Kabi said the European Medicines Agency will review its product application for a pegfilgrastim biosimilar.

Here are the top 5 biosimilars articles for the week of May 18, 2020.

A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.

Fresenius Kabi’s pegfilgrastim biosimilar candidate has demonstrated a similar safety and immunogenicity profile to the reference product (Neulasta).

After completing a 24-week phase 3 trial, Samsung Bioepis said its biosimilar ranibizumab (SB11) has demonstrated clinical equivalence to reference Lucentis for the treatment of neovascular age-related macular degeneration.

Taiwan-based JHL Biotech said it has initiated a phase 1 clinical trial of its denosumab biosimilar candidate for bone loss.